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Lastly, the net effect of all of these procedures is to

ensure that whatever information manages to trickle down

through them is at best stale.

Layer upon layer of delay is

built into the proposal. While the proposal plays lip service to this problem by including a provision allowing the requester to challenge what appear to be unwarranted extensions of time, the protections afforded by this provision are, in practical terms, illusory. The District of Columbia

Circuit Court of Appeals has already ruled that agencies may

justify failing to adhere to the time provisions spelled out

in the Act simply by establishing that they are using good

faith efforts to process requests.

Open America v. Watergate

Special Prosecution Force, 547 F.2d 605 (D.C. Cir. 1976). Given the administrative problems agencies presently face simply in processing requests, there is every reason to believe that saddling agencies with the myriad procedural

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hearings come at a critical time. In May, the Attorney General signaled that the Justice Department will once again be willing to go to court to litigate POIA cases, even where

the agency cannot point to a demonstrable harm which would

flow from disclosure. The proposal pending before this Committee, which, if enacted, would build a brick wall

between the public and all government records concerning corporate interaction with government, is another step in the wrong direction. We therefore urge the committee to take a hard look at the evidence evidence which unequivocally demonstrates that exemption 4 as presently drafted fully protects the legitimate rights of corporate submitters.

Thank you.

Senator THURMOND (acting chairman). Considering your knowledge of agency practices, would you favor the giving of notice of disclosure to the real party in interest, in addition to the one who might have supplied the documents to the agency? Are there circumstances under which you would prefer that no notice be given to the submitter before disclosure of its private data occurrence?

Mr. VLADECK. I think that notice, as a general rule, ought to be given to the submitter. I think there are categories of cases where notice is not necessary. For example, where the data at issue is required to be disclosed as a matter of law.

There are other instances as well. By and large, we do support the notion that submitters ought to be notified.

Senator THURMOND. How often do your organizations bring lawsuits seeking disclosure outside of Washington? Would you object if a submitter who was residing in Utah or Kansas wanted to sue in his own home district to restrain the regional office of some Federal agency from disclosing his private information?

Ms. CAMPBELL. Many of our cases are in Washington.

I think that the concern we have and the reason we advocate a preference as under current law for the forum of the requester really is the result of the kinds of clients that we represent-people of limited resources who would have difficulty participating in a case if it were outside of the area where they live or where their counsel have offices.

On the other hand, these are problems that are common in many kinds of litigation in the Federal courts. As I suggested in my testimony, one possibility is simply to resolve them as they are resolved in other instances, which is to permit the court to determine which is the appropriate forum and who would be most harmed or prejudiced by a transfer of venue in a particular case.

Senator THURMOND. Ms. Campbell, you have opposed de novo review in the past when submitters have asked for it on grounds that the agency's record is sufficient for review. Yet you also support faster handling of the submitter's claim and less time for considering his confidentiality arguments which would reduce the agency's record. Can you explain this?

Ms. CAMPBELL. I think that there are two problems. One is what happens if we do not amend the law? The second is what would happen in the best of all possible worlds if we could amend the law?

I think that the problem right now, without amendment of the law, is one in which different agencies take different amounts of time. They essentially do not follow the time periods set forth in the act. I think too much time is given to developing the record in some cases and not enough time in other cases.

Therefore, I have advocated a procedure under which the time period would be extended from that in the current law but not extended as far as some have proposed. Again, I think that 30 days, approximately, is a reasonable time. I would note that that is the time period generally advocated by the Stevenson report. I think he advocates 40 days, whereas I advocate 30 days. I do not think that is a distinction with a difference.

I think the problem occurs when you get into these 90-day time periods. Whether it is 30 or 40 days, that is an adequate time to develop the record.

Senator THURMOND. Mr. Vladeck, your health research group has been a prodigious user of the Freedom of Information Act. Can you estimate how many FOIA requests you have made in the last year?

Mr. VLADECK. I believe that the health research group has made approximately 300 FOIA requests to the Food and Drug Administration alone in the last year. That is the agency with which it principally deals.

Senator THURMOND. How many of these were granted in full or in part?

Mr. VLADECK. I would be delighted to supplement the record with a letter. I do not know offhand.

I know, however, that the bulk of them are granted in full. A significant percentage, perhaps roughly 10 percent are denied either in full or in part.

Senator THURMOND. Do you know how much money and agency fees were waived by the agencies in response to your request for fee waivers?

Mr. VLADECK. I do not believe the agency informs you of how much money is being waived when they grant a fee waiver. They simply tell you that your fees will be waived.

I cannot even estimate that.

Senator THURMOND. Could you get that up and furnish it for the record?

Mr. VLADECK. I would be delighted to. [Material to be supplied follows:] I have been informed by senior members of FDA's FOIA staff that an estimated $4,600 in reproduction costs were waived during 1980. An estimated additional $5,000 in reproduction costs were waived during the first seven months of 1981.

Senator THURMOND. Could you describe a scenario in which information of vital public interest would be withheld under the S. 1247 standards which would be available for lease under the current competitive harm test?

Mr. VLADECK. Yes, sir; I can. For example, let us stick with the FDA if you do not mind.

We recently litigated a lawsuit involving access to test data submitted in support of new drug applications-in this case, investigation of new drug applications—concerning drugs that were still in the experimental stage.

The data that we compelled disclosure of evidenced that the drug companies involved had begun testing these drugs on humans prior to completing animal studies.

These animal studies ultimitely showed that the drugs were carcinogenic.

The drug would never be marketed. Hence, the manufacturers do not have a strong claim under the National Parks test that the material we sought access to was exempt. After all, there would be no competition.

We believe that this kind of data-data showing that drug companies were unfortunately, and perhaps needlessly, exposing human subjects to drugs that had not been adequately tested first on animals—is of vital and legitimate public concern and raises very serious questions about the methodology employed in testing drugs.

Without the Freedom of Information Act, this information would never have come to public light and certainly would never come to light if the provisions of S. 1247 are adopted.

Senator THURMOND. Mr. Vladeck, we understand that the health research group conducts a subscription service for $280 per year for lawyers who are suing manufacturers of certain medical device products.

Does the group charge subscribers for documents which it obtains for free under the fee-waiver provisions of the Freedom of Information Act?

Mr. VLADECK. No. The only costs that are charged to the subscribers are Xeroxing costs-just our costs of reproduction.

Senator THURMOND. Mr. Braverman posed an example of where disclosed information has no competitive value because it is a new invention and not yet marketed. How would you address this inadequacy in the National Parks standard?

Mr. VLADECK. My first question to Mr. Braverman would be how that information ended up in Government files.

You do not file that sort of information with the Government until you are ready to seek either marketing approval or testing approval from the Government. That sort of information has historically been protected under the common law trade secret laws.

Unless and until it has some potential commercial value, it would not end up in the files of the Federal Government.

Senator THURMOND. Senator Grassley, do you have any questions of any of these witnesses?

Senator GRASSLEY. I do not. I am sorry but I got here late, and I am not prepared to ask questions at this time.

If I have any, I will have to submit them in writing.

Senator THURMOND. We will give you a chance to ask them if you want to.

Senator GRASSLEY. Thank you very much, Mr. Chairman.

Senator THURMOND. Is there anything else either of you wish to say?

No response.]
Thank you for your appearance.

Senator THURMOND. Our final panel today will represent many of the businesses and nonprofit institutions affected by FOIA's exemption 4.

Will you gentlemen please identify yourselves and tell us who you represent?

Mr. KEYES. My name is Joseph Keyes. I am the staff counsel to the Association of American Medical Colleges. I am accompanying Dr. Stuart Bondurant who is presenting the statement.

Dr. BONDURANT. I am Dr. Stuart Bondurant, dean of the University of North Carolina, School of Medicine. I am presenting a statement on behalf of the Association of American Medical Colleges.

Mr. VIRDEN. I am Prospere Virden. I am senior counsel at Honeywell, and I am presenting a statement on their behalf.

Mr. WHALE. I am Arthur R. Whale, general patent counsel and assistant secretary for Eli Lilly & Co., for whom I am presenting a statement.

Senator THURMOND. I believe the first witness on the panel is Mr. Whale, assistant secretary and general patent counsel for Eli Lilly & Co. since 1975.

Mr. Whale is a past president of the American Patent Law Association, past chairman of the National Council of Patent Law Associations, and past president of National Inventors Hall of Fame Foundation.

Mr. Whale, you may proceed.
STATEMENT OF ARTHUR R. WHALE, GENERAL PATENT COUN.

SEL AND ASSISTANT SECRETARY, ELI LILLY & CO., INDIAN-
APOLIS, IND.
Mr. WHALE. Thank you, Senator Thurmond.

Our main business is the high technology, research-intensive development of new drugs, electronic systems for hospital uses, agricultural products-mostly of a chemical nature—and cosmetics.

In complying with the various Federal regulatory procedures, we deliver information consisting of trade secrets to the Food and Drug Administration, the EPA, and to a number of other agencies-to agencies implementing a number of Federal statutes.

In fact, some of these agencies implement a number of Federal statutes which result in a variety of rules and regulations and procedures and philosophies with which we must contend in dealing with the Freedom of Information Act.

We give a large number of different types of information to the various Federal agencies, as you can imagine, because we are indeed a highly regulated industry.

Of perhaps most concern is the information of a process nature which we provide to FDA, EPA, OSHA, and to other agencies.

Taken together, this information reflects the techniques that have been developed in-house, the raw materials with which we work, the processes which we have evolved, the particular temperatures, pressures, research conditions, and purification procedures that combine to make our products ready for the regulatory agencies to approve.

We are very concerned at possible losses of information like this. We are constantly faced with demands, and properly so, for information concerning the effluents from our stacks and from our point-source discharges and the nature and disposition of hazardous wastes with which we must contend. But we are also concerned with what happens to this information in the hands of the Government agencies, because much of it can be reverse engineered to learn exactly what processes we use--for example, what solvents we might have found most suitable to give us the best process economics.

This information all comes from our research and development programs which in 1980 cost in excess of $200 million.

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