GOVERNMENT
J. Jerome Thompson Present rules stifle research
Rep. James J. Delaney (D.-N.Y.) Changes would weaken food additives act
Change in Feed Additive Rules Urged Industry and FDA back bills to permit the use of suspected carcinogens under special conditions Rigid interpretation of the Delaney anticancer clause in the Food Additives Amendment stifles research on improving animal feeds and gives some feed manufacturers a competitive advantage over others. This was the testimony of industry representatives at hearings before the Subcommittee on Health and Safety of the House Commerce Committee on H.R. 12420 and 12437. These bills would permit the use of suspected carcinogens in animal feed if the additive does not harm the animal and no residue remains in the animal's flesh. The Food and Drug Administration also supports the proposed legislation. But Rep. James J. Delaney (D.-N.Y.) opposes the bills because he believes they would weaken the anticancer provisions of the Food Additives Amendment to the Food, Drug, and Cosmetics Act. The principal problem is the use of diethylstilbestrol, widely used in cattle feed as a growth stimulator. Under the FDA interpretation of the Delaney anticancer clause, a firm cannot use DES in animal feed unless it had approval from FDA to use the alleged carcinogen before the Food 30
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Additives Amendment was passed in 1958. Bar to Research. "The Food Additives Amendment as now interpreted and applied to animal feed has sharply reduced the incentive for research in this field," J. Jerome Thompson, vicepresident of Pfizer, told the committee. The reason is that FDA refuses to make effective any new drug applications for feeds containing DES or certain arsenicals, he says. About 80% of manufactured cattlefeeds today contain DES to stimulate growth and improve feed efficiency, Mr. Thompson says. And under FDA rules, these feeds can continue to be marketed as long as there are no changes in composition, manufacturing procedures, labeling, and the like. Because DES is effective and relatively inexpensive, its use by feed manufacturers is not likely to decline, Mr. Thompson says. Hence, if a newlydeveloped drug is to be a commercial success, it must be added to the exempt feeds which already contain DES. Otherwise, he says, the market for a new drug would be very limited, since it could only be used in feeds which contain no DES.
The practical effect of the FDA rule, he says, is to bar automatically the use of any new drug in 70 to 80% of the manufactured animal feeds marketed today. Since there is little incentive to develop new drugs for use in animal feed, drug manufacturers have sharply curtailed spending for this type of research, he says. The ruling on DES creates a discriminatory competitive situation in the feed industry, W. E. Glennon, president of the American Feed Manufacturers Association, told the committee. Feed producers who had clearance to use DES prior to September 1958 can continue to use the material while those without prior approval cannot. And under the rigid rule forbidding changes in procedure, he says, "Some feed manufacturers that have recently built new and modern feed mills have been faced with an astonishing situation that prevents them from using these ingredients in their new plants yet allows them to continue using them in older facilities." He urges the committee to approve the bills. Unfair. The Food and Drug Administration recognizes the unfairness of this situation and the inequities that have been created, John Harvey, deputy commissioner of FDA, told the committee. The proposed bills would relax present law to correct these inequities, he says. FDA backs these bills bacause there is no hazard to health if stilbestrol is used in accordance with approved directions, Mr. Harvey says. And, he adds, the bills contain these safeguards: FDA would be authorized to prescribe tests to determine if any of the chemical remains in food derived from treated animals, and, if scientific evidence raises substantial doubt as to whether the chemical should be used in feed, the Food and Drug Administration would have the power to withdraw its approval. Opposition. Rep. Delaney strongly opposes the bills. As he sees it, the proposed legislation would weaken the protection against cancer-inducing substances provided by the Food Additives Amendment. According to Rep. Delaney, permitting some manufacturers to add DES to cattle feed under a "grandfather clause" is a mistake. In his opinion, the law should be amended to repeal the grandfather clause rather than amended to permit more manufacturers to get into the field.
