Morton-Norwich Products, Inc. v. Mathews, Civ. A. No. 76-0128.

• Decision Date: 29 March 1976
• Docket Number: Civ. A. No. 76-0128.
• Citation: 415 F. Supp. 78
• Parties: MORTON-NORWICH PRODUCTS, INC., Plaintiff, v. David MATHEWS, Secretary of Health, Education & Welfare, and Alexander M. Schmidt, Commissioner of Food and Drugs, Defendants.
• Court: U.S. District Court — District of Columbia

415 F. Supp. 78

MORTON-NORWICH PRODUCTS, INC., Plaintiff, v. David MATHEWS, Secretary of Health, Education & Welfare, and Alexander M. Schmidt, Commissioner of Food and Drugs, Defendants.

Civ. A. No. 76-0128.

United States District Court, District of Columbia.

March 29, 1976.

Robert H. Becker, Alan H. Kaplan, Washington, D. C., for plaintiff.

Peter C. Schaumber, Asst. U. S. Atty., Washington, D. C., for defendants.

MEMORANDUM AND ORDER

GESELL, District Judge.

This is another Freedom of Information Act case. Following its now-settled practice, the Court requested the Government agency to submit samples of the documents for which exemption from disclosure is claimed in order to focus the issues in an adversary context. This was done, aided by some discrete excerpting, and the controversy was briefed and argued.

At stake are some 49 documents out of hundreds requested and disclosed following an elaborate file search and administrative clarification of what was sought. The documents still in controversy are claimed to be exempt under (b)(2) and (b)(5), 5 U.S.C. § 552. The claim of exemption is supported by an affidavit from a responsible, informed official. Appropriate indices were furnished, together with the sample documents. The parties cross-moved for summary judgment. There is no factual dispute. The Court must accordingly attempt to interpret what the Freedom of Information Act means when applied to the circumstances of this case.

Three requests of plaintiff are still opposed by the agency and form the basis of this litigation. The first contested request seeks

a copy of each memorandum or other record or document relevant to the controls and procedures utilized between January 1, 1965 and October 15, 1975 to eliminate possible laboratory contamination in the facilities operated by or on behalf of the Food and Drug Administration for the performance of sterility tests.

Two categories of documents within this request have been withheld: (1) worksheets showing quality assurance sterility sample results of analyses conducted in 1972 and 1974 on "audit" samples, and (2) inter-agency memoranda containing selective portions of the results of the samples, analyses of the results, and recommendations for changes in laboratory operation, analytical procedures and/or additional training.

Plaintiff's second request seeks to obtain a copy of each memorandum or other record or document prepared between January 1, 1965 and October 15, 1975, pertaining to the need or desirability of changes in the design, construction materials, structure, or equipment in facilities operated by or on behalf of the Food and Drug Administration for performing sterility tests.

Included in these documents are specific cost estimates supporting the budget needed to make proposed changes. A sample was again provided.

The final dispute concerns plaintiff's request for

a copy of each memorandum or other record prepared between January 1, 1965 and October 15, 1975, pertaining to the need or desirability of changes in the sampling and laboratory procedure in use by each laboratory of the Food and Drug Administration for testing (a) sterile impregnated gauze pack and/or (b) other sterile products.

Three classes of documents are within this request. First, there are 23 intra-agency memoranda reflecting the on-going pre-decisional deliberations of, summaries of meetings by, and correspondence between the members of, an internal FDA working group known as the Task Force on Sterility. No representative sample is provided, but the memoranda have been clearly indexed. Also withheld are memoranda containing discussions of possible modifications of analytical procedures and controls utilized in performing sterility testing. A sample document has been made available. Finally, the agency refused to reveal two interagency memoranda containing recommendations of personnel from the Center for Disease Control of the Public Health Service and the Food and Drug Administration concerning a draft set of Good Manufacturing Practice regulations (GMPs) for large volume parenteral products.

The defendants claim exemption under (b)(2) and (b)(5) for the first category and again invoke a (b)(5) exemption as to all the other requests in dispute as summarized above.

Certain benchmarks, well established by prior decisions, serve as initial guides in interpreting and applying the statute. A person requesting information is not required to show a need or a reason, and an agency must disclose wholly useless, meaningless and misleading information unless it is exempted. Where exemption is claimed, as here, the exemption must be narrowly construed, and the burden of proof is on the agency, e. g., Washington Research Project, Inc. v. Department of Health, Education & Welfare, 164 U.S.App. D.C. 169, 504 F.2d 238, 244 (1974), cert. denied, 421 U.S. 963, 95 S.Ct. 1951, 44 L.Ed.2d 450 (1975). Against this background, the Court turns to the specific requirements of the exemption.

The Court finds that (b)(2) does not support the agency's refusal to release documents in the first category. The material relates neither to minor or "housekeeping" matters nor predominantly to internal personnel rules and practices of the agency, but rather to the substantive performance and competence of the FDA in this area. Moreover, plaintiff has agreed to the deletion of the names of both the employees tested and the employees' supervisors, and therefore the aspects of the documents which might otherwise relate to personnel practices have been eliminated. Accordingly, under the opinion of either Judge Wilkey or Judge Leventhal in Vaughn v. Rosen, D.C.Cir., 523 F.2d 1136 (1975), the (b)(2) exemption is not available.

It remains to consider the (b)(5) claims as to all of the materials in controversy.

The Court has before it here primarily documents that recommend or are, as in the case of the Task Force papers, clearly developed in aid of a recommendation. Thus the papers are unquestionably an integral part of the agency's deliberative processes. All of the documents fall directly under the (b)(5) exemption, and the agency may refuse to produce any material that contains opinions, advice, evaluations, deliberations, policy formulations, proposals, conclusions or recommendations. The issue is whether factual statements found in these deliberative documents must be disclosed or also treated as exempt along with the rest of the text. If this proposition were presented as a matter of first impression, the Court would favor a rule of thumb to the effect that any document containing an explicit recommendation and legitimately prepared in the regular course of the agency's business to further its deliberative process is exempt in its entirety. It appears that...