Volume 3

Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963.

United States. Congress. Senate. Committee on Government Operations

Date:: 1963

Credit: Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963. Source: Wellcome Collection.

433/504 page 1199

paper is not available and apparently should not be listed among our refer- ences on this subject. * * * We are not in a position to make our copy of the paper available.” With this polite but decisive bureaucratic brushoff ringing in his ears, the patient put persevering inquirer wrote to the Meat Inspection Division of the Department of Agriculture. Their reply was astonishing and disquieting. Said the Meat Inspection Division, “Both the antioxidants which you men- tion [BHA and BHT] have been exhaustively studied by comprehensive animal feeding studies. * * * the toxicity studies were not conducted by a Govern- ment agency but by private companies * * * under the direction of this Divi- sion. * * * The data resulting from the feeding experiments is in our files but is not available for distribution since it was furnished to us in confidence. We do not know whether the results of these studies have been published. * * * We do not have a copy of the paper to which you refer, entitled, Summary of Toxicity Studies on Butylated Hydroxyanisole.” [Italics ours. | So, this was the end of the long and time-wasting search for the much cited “Summary.” The agency to which it was supposedly submitted did not have a copy—and what information they did have about the toxicity of BHA was “confidential.” Another tax-supported agency which did have a copy was “not in a position” to make its copy available, meaning that the agency did not con- cede that consumers have any right to read and judge the validity of information which the Government thinks good enough to provide a basis for adding a more or less poisonous substance to hundreds of items in our food supply. It is very disturbing to know (1) that the Government’s basic data from which was decided the “safety” of BHA and BHT were supplied from private sources which have an evident commercial interest in the products, (2) that these scien- tific data and the reasoning whereby they were interpreted are not availabie for critical examination by any person outside the Government service, and (3) that the Meat Inspection Division which originally approved use of these chemi- cals in food is so backward in its studies of relevant scientific literature that they “do not know” what has been published on the subject. The chances are good for the general correctness and truthfulness of published scientific studies, or for their fairly prompt correction if wrong in some major respect, because papers published in scholarly journals are often read critically by experts in the fields concerned, and normally by some experts who have no financial stake in the matters discussed. This safeguard, of course, can not apply to studies which emanate from commercial sources and are kept as secret information in the files of a Government bureau, available only to Government officials and administrators, or perhaps to certain representatives of industry. References listed as sources at the end of a published scientific paper are assumed, unless stated otherwise, to be available to interested persons. Listing of the secret “Summary” by authors of the papers on BHA was a violation of a sound and widely accepted rule. It is hard to account for, except on the assumption that there is something that needs to be kept from public review. One wonders whether the secret paper was at any time made available to the various authors of papers which cited it (and if so, by whom), or whether they relied on abstracts, merely, or other second-hand reports about its contents. As the number of chemical additives tolerated in foods keeps rising (well over 3,000 now), it becomes increasingly urgent that all experimental work claimed to show their safety be exposed to public scrutiny and review by any interested independent expert. Governmental authorities should give no weight at all to data on toxicity which are supplied “in confidence,” or to information which is restricted in any way so that it cannot be made freely available to anyone interested. This does not mean that secrets of manufacturing methods need be publicly disclosed—but no chemical product should even be considered for addition to food unless its exact chemical formulation is known and the results of tests alleged to show its safety are made generally available at any and all times to all who may be interested. HOW SAFE ARE BHA AND BHT? The papers we were able to find revealed some interesting facts and judgments about BHA. The earliest of the references was to a study, published in 1956 by three scientists in New Zealand. “Although studies of the conventional type on acute and chronic toxicity have been made,” the authors said, “no studies on metabolism [how the material is utilized or is changed in the body] have been

Licence and re-use

Contents

Volumes