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MORTON-NORWICH PRODS. v. MATHEWS

March 29, 1976

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



The opinion of the court was delivered by: GESELL

 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. ยง 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.


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