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FREEDOM OF INFORMATION ACT

THURSDAY, SEPTEMBER 15, 1977

U.S. SENATE,

SUBCOMMITTEE ON ADMINISTRATIVE

PRACTICE AND PROCEDURE,

COMMITTEE ON THE JUDICIARY,
Washington, D.C.

The subcommittee met, pursuant to notice, at 10 a.m. in room S-126, the Capitol, Hon. James Abourezk (chairman of the subcommittee) presiding.

Present: Senators Abourezk and Thurmond.

Staff present: Irene R. Emsellem, chief counsel and staff director; Diana Huffman, counsel; and Robert Lyon, counsel to Senator Thurmond.

Senator ABOUREZK. The meeting will be in order.

This is the first of a series of hearings on the Freedom of Information Act to determine essentially how it is working and what, if any, amendments are needed to make it work better.

OPENING STATEMENT OF SENATOR ABOUREZK

Eleven years ago Congress, by passing the Freedom of Information Act, recognized that public access to Government information was essential to an open and democratic Government. Early experience with the law demonstrated that, despite the high hopes for that legislation, it failed to open up Government files to the public in any significant degree. As a result, the act was amended extensively in 1974.

The development and oversight of the original bill and amendments has centered in the Senate in the Administrative Practice and Procedure Subcommittee. Today, we continue that important role as we begin the first formal oversight hearings on the act since the 1974 amendments took effect. The hearing will continue tomorrow and resume on October 6.

The preoccupation with secrecy in Government, documented by the Watergate scandal, is not so remote that we can allow congressional vigilance of implementation of the Freedom of Information Act to abate. Certainly, we have made great strides in opening up Government information to the public since the 1974 amendments. More information has since been released under the act. The Carter administration's expressed commitment to openness, coupled with the Attorney General's specific directive last May to increase compliance with the spirit and letter of the act,2 provide a basis for optimism about the future of the Freedom of Information Act.

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During these 3 days of oversight hearings, we will attempt to determine the degree to which executive branch compliance with this mandate of the law has improved during the past 2 years, whether the Attorney General's directives to reduce the overwhelming backlog of administrative and judicial appeals under this act are being heeded, and what can be done to insure and enhance future compliance.

Today, the subcommittee will focus on problems raised by one of the most vexing and complex areas under the act-the (b) (4) or so-called trade secrets exemption, and the reverse Freedom of Information Act cases it has spawned.

Congress intended the exemption to protect both trade secrets and financial or commercial information that is privileged and confidential. The area of trade secrets always has been sticky. However, the second part of the exemption, dealing with confidential information, has proven more difficult in recent years.

Business rightfully is concerned about competitive dangers resulting from disclosure of information it submits either voluntarily or as required by statute to the Government. Yet, not all such information should be withheld as the public often has a legitimate interest in seeing some of this information. Balancing these competing interests is the task confronting the agencies that possess the data. For example, the Federal Trade Commission and the Federal Power Commission recently supported utility companies claims that release of fuel data. submitted to the Government would hamper negotiations with fuel suppliers.2

I question whether this decision is truly in the public interest and whether at least some of this data could legitimately be released without adverse impact on the utility companies.

The subcommittee will analyze current agency disclosure practices under the (b) (4) exemption. It will try to determine if this Freedom of Information Act exemption and the plethora of other conflicting Federal information statutes hamper intraagency sharing of information, and prevent vital health, safety, and economic information from reaching consumers.

For instance, the Food and Drug Administration must wrestle with the problem of how much information about new drugs can be released to the public. FDA regulations implementing the confidentiality section of the Food, Drug, and Cosmetic Act preclude the publication of some results from safety and efficacy tests performed on new drugs.3 The Environmental Protection Agency faces a similar dilemma regarding toxic chemical data. I am concerned that the public's right, under the Freedom of Information Act, to know this information is being undercut by conflicting statutes governing individual agencies' operations.

The subcommittee also will consider the procedural problems posed by reverse cases-suits brought by submitters of information to prevent disclosure by agencies to third parties. The issues raised range from whether the submitter should be notified of any impending release, to whether the requester always should be a party to a reverse suit.

1 See legislative history at p. 419 of the appendix.

2 See pp. 315, 423 of the appendix and p. 11 of hearing text.

3 See p. 340 of the appendix and p. 20 of the hearing text. See p. 394 of the appendix and p. 25 of the hearing text. 5 See p. 424 of the appendix.

Finally, the subcommittee will consider whether congressional intent in passing the Freedom of Information Act is being contravened by the extensive use of the act for commercial purposes.1

I would like to ask all of the witnesses if they would forego reading their statements and just highlight what they think is important. That will give us more time to ask questions and to have a discussion. All of your statements will be printed in the record as though read. Mr. Gardner?

TESTIMONY OF SHERWIN GARDNER, DEPUTY COMMISSIONER, FOOD AND DRUG ADMINISTRATION, PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, ACCOMPANIED BY STUART PAPE, OFFICE OF CHIEF COUNSEL, FOOD AND DRUG DIVISION, FOOD AND DRUG ADMINISTRATION

Mr. GARDNER. Mr. Chairman, I am Sherwin Gardner, Deputy Commissioner of the Food and Drug Administration. With me today is Stuart Pape, Associate General Counsel for the Food and Drug Administration.

I will offer my statement for the record, Mr. Chairman, and make two or three points to summarize the statement.

We deal with the trade secret exemption and reverse freedom of information lawsuits. I think it is important to note also that the agency has encountered a significant workload in administering the provisions of the Freedom of Information Act. We have compiled information on the extent that it impacts on the agency. To a certain extent, that workload is associated with the trade secret provisions of the act.

The agency receives a great deal of information submitted by companies seeking to market drugs, food additives, and other products. That information contains within it some data which are considered to be trade secrets-entitled to protection-as well as a great deal of other information not entitled to protection and which can be ultimately disclosed. The problem is that that information is intermingled in the submissions. It requires a great deal of effort to separate it out. So, one of the problems we have is that the cost of separating the data is quite excessive and seriously detracts from the other work of the agency and from making available information that people request and to which they are entitled.

We have published regulations 2 in a great deal of detail which help to circumvent that sort of problem by categorizing exactly what sorts of records the agency does have and what is contained in them-to the extent that we can describe that generically-and which deal rather specifically with the kinds of things that are considered to be trade secret information and those which are not. That set of ground rules, then. is an invaluable aid in helping to avoid contests over what is releasable and what is not; although it has not avoided contests entirely, we think it has helped keep them to a minimum.

1 See p. 425 of the appendix and p. 29 of the hearing text.

* See pp. 329, 345 in the appendix.

We have had experience with one reverse freedom of information suit. Although those kinds of suits are undesirable, in a sense that sort of a suit is helpful in that it helps to define the ground rules. If we should get additional suits and have to defend those, I think it would be detrimental to the administration of the act and the agency's business.

I think I will stop there and allow the other witnesses a chance. Senator ABOUREZK. Thank you very much. Your prepared statement will be inserted in the record.

[The prepared statement of Mr. Gardner follows:]

PREPARED STATEMENT OF SHERWIN GARDNER

Mr. Chairman, The Freedom of Information (FOI) Act and the Food and Drug Administration's (FDA) implementing regulations have been important instruments for greater consumer participation in the affairs of the agency. We appreciate, therefore, the opportunity to participate in today's discussion of how the FOI law is working at the present time. As requested in your letter of invitation, I will deal specifically with two subjects: the trade secret exemption and reverse freedom of information lawsuits.

IMPACT OF FOI ACT ON FDA

Before discussing those two subjects, I would like to make a few general observations about the impact of the FOI Act on FDA over the past few years. When our Public Information regulations were first proposed in May 1972, they represented a major change from prior agency policy. Before then FDA, like most other agencies, retained most of the records in its files as confidential. Thus, we estimate that before our regulations went into effect, 90 percent of FDA's records were considered confidential; the same percentage of our records are now routinely disclosed.

While the objectives of the act have generally been achieved, it has also resulted in some heavy costs to the agency. The volume of requests has been greater than we anticipated. While in 1975 we received roughly 13,000 FOI requests, by 1976 we had received over 21,800. We are receiving upwards of 470 requests per week, many demanding voluminous documents and raising complex release policy issues. It is not at all unusual to receive requests asking for every record in FDA's possession on a particular topic. These requests are time-consuming and costly.

The agency estimates its uncompensated cost responding to all FOI requests exceeded $1 million in 1976. Fees which we are able to charge for requests produced only $96,000 in revenue (which, I might add, is not available for use by FDA).

The number of people working on FOI requests has also necessarily increased with the increase in requests. In 1974, seven person-years were spent on FOI: in 1975, this figure increased to 43 person-years and ballooned again in 1976 to 67 person-years.

The agency has been forced to absorb most of the staffing requirements of FOI. Because our scarce regulatory resources are being spent responding to FOI requests, money and personnel are being diverted from other programs designed to carry out the agency's mission of protecting the consumer. FDA scientists and other professionals, including medical officers, are too frequently diverted from their regular work to identify and analyze complex and sensitive FOI requests which cannot be handled by clerical personnel.

However, the average citizen is not the main beneficiary of our work on FOI requests. Individual citizens were responsible for only eight percent of FDA's FOI requests in 1976 and the press and public interest groups were responsible for only about five percent. Most of the agency's FOI requests-more than 80 percent in 1976-originated from industry or persons working on their behalf. Indeed, it is difficult to avoid the conclusion that FOI is substantially being used as a means of corporate intelligence gathering. This certainly is not what the FOI Act was designed to achieve.

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