42 —Lancaster Farming, Saturday, September 15,1979 WASHINGTON, D.C. - The most widely used livestock qrugs, including a list of, products named just last month as among the safest on the market, would face prolonged and costly new testing under a Food and Drug Administration (FDA) proposal called “SOM.” The “SOM”, or Sensitivity jof Method, proposal was commented upon officially on September 4, by the .Animal* Health Institute (AHI), the national trade association for the major manufacturers of the animal health products used by U.S. livestock producers. “The SOM proposal. In its current form, threatens the continued availability of most, if not all, of the widely used drugs presently ap proved by FDA for use in protecting the health and promoting the growth of food-producing animals,” according to Mr. Fred H. Holt, AID'S President “If pot into effect unchanged, ‘SOM* would threaten the very future of animal health product research in this country,” Mr. Holt added. As with a previous proposal offered in July 1973, AHI said it supports the philosophy behind the FDA’s effort to interpret the animal drug exception to the Food, Drug and Cosmetic Act’s so called “Delaney anti-cancer Clause.” However, the trade association was critical of the proposal’s scope and offered its own alternative proposal IF YOU'RE LOOKING FOR A REAR TILLER - • DISENGAGE TINES WHILE DRIVING TO AND FROM GARDEN (brp. only) • DISENGAGE WHEELS • BRIGGS & STRATTON ENGINE • 5 FORWARD SPEEDS W/REVERSE • 9 position Handle - up - down LEFT-RIGHT 5H.P., BH.P AUTHORIZED DEALER LAWN CARE OF PA. SALES & SERVICE Martindale, PA 17549 Phone: 215-445-4541 1 mile north of Martindale on Grist Mill Road. Mon., Tues., Thurs 4Fri Bto 8; Wed. 8 to 5; Sat. 8 to 2 FDA proposal threatens animal drugs The “SOM” proposal, in concept, is designed to provide a scientific definition of what the animal drug provisos means when it says no residues of a car cinogenic drug are to be found in food from treated animals. AHI endorses the idea that safe levels can and must be established for these residues. Without such a definition, AHl’s President said, “government and industry will continue to chase the latest definition of ‘zero residues’ as defined by the newest residue detection test, without ever telling the public what is or is not safe.” AHI said it continues_tp believe that a workable “SOM” procedure can be developed. Holt said AHI offers an alternative for each step of the FDA procedure. AHl’s alter native, he added, assure the safety for the consumer while protecting the health and production efficiency of ■ food-producing animals. An essential feature of the “SOM” proposal is its threshold assessment system, according to AHI. This system is used to determine whether an animal drug will undergo further testing, which FDA admits will cost at least $4.3 million per product. FDA says it has 648 drugs currently approved for food animal use. AHI estimates that in 1978, the combined annual sales of food animal drugs totalled $B9l million, according to a survey of its member firms. “It would be List . $749 $ 599 $879 *725 economic foolishness for a manufacturer to spend $4.3 million or more to test a drug whose annual sales may be less than $1 million a year,” AHl’s President ,said. “Under these conditions, a drug that fails ‘threshold assessment’ and faces full testing under ‘SOM’ would simply be withdrawn from the market by the manufacturer.” How many drugs may face the full brunt of “SOM?” In mid-August, FDA’s Bureau of Veterinary Medicine (BVM) categorized animal drugs according to 'their teiauve humi'n safety, BVM described its “Category r drugs as having the highest degree of human safety based on the amount a safety data provided by th< manufacturers and available in the scientific literature. AHI estimates that at least nine, and possibly more, of BVWTs “Category I” drugs would have to undergo “SOM”-required testing under FDA’s proposed threshold assessment scheme. The nine include: amprolium, chlor tetracycline, erythromycin, lincomycin, oleandomycin, oxytetracydine, penicillin, tylosin and virginiamycin. All are among the most widely used animal drugs. It’s because of their ex tensive use that most would SALE SHENK'S FARM SERVICE THINKING...OF BUYING A MILK TANK? ACTNOW BEFORE PRICE INCREASE COMING SEPT. 15 TCIID Mil ISO The A " New I CmrmH I lU REFRIGERATION system USED TANKS 3000 Gal. Dari-Kool w/2 new compressors 735 Gal. Sunset 625 Gal. Sunset (2) 600 Gal. Mojonnier’s (l SOLD) (2) 500 Gal. Mojonnier Vacuum's 600 Gal. Esco Vacuum (for liquid fertilizertank, etc.) D-4 400 Gal. Girton D-2 400 Gal. Girton • PLANNING LAYOUTS • SALES • INSTALLATION • SERVICE 501 E. WOODS DRIVE, LITITZ, PA 17543 PH: 717-626-1151 ★ OUR SERVICE iftUCKS ARE RADIO DISPATCHED ★ 24 HOUR SERVICE likely fall under “SOM’”s testing requirements. AHI scientists and regulatory experts who prepared the Institute’s “SOM” comments found the proposal would have the foilin'* unpacts: .>ii but a few of the food animal drugs currently listed in the Feed Additive Compendium, the unofficial guide to feed-use drugs, would be subject to the costly and time-consuming new tests. - Today’s most advanced technology cannot provide some of the answers required by FDA’s “SOM” proposal; and the effort needed to do the other research work demanded would strain the nation’s scientific capacity severely. • Hie testing necessary to find a sensitive - enough method for detecting drug residues in food, under “SOM”, could be the most costly requirement of all. One AHI member firm reports spending over $2 million on the residue test for one product and expects to spend even more before FDA approves a method. This is more than four times the FDA estimate for the cost of the residue test development under the proposed “SOM” regulations. - The sensitivity of the tissue residue tests that “SOM” may require could be beyond the capability of even the most modern government laboratory and may be altogether beyond the range of present technology. - The present proposal would probably increase the cost of food to the consumer by reducing livestock production efficiency and increasing losses due to animal disease because of the loss of drugs under “SOM”. In place of the FDA proposal, AHI suggests an alternative under which only drugs shown to be car cinogenic would be subject to the “SOM” regulation. AHI says the law provides that only cancer-causing compounds can be regulated under the “no residue” requirements of the animhl drug provision to the Delaney Clause. Animal drugs that are net car cinogenic would continue to be regulated under the general safety provisions of the FD&C Act, noted AHI. This part of the Act requires that a drug be shown to be safe for animals and man, but does not subject them unnecessarily to the more severe restrictions man dated by the Delaney Clause for carcinogens. “AHI feels that its alternative proposals will accomplish everything the FDA version attempts to do,” Mr. Holt said. “But, AHI uses a much more Which Makes it The Number 1 Cooler! Featuring: • Built-in recorder. • No Problems with Interval times. • Interval timer agitates milk 4 different times in one hour, • Built-in warning system - A horn or light warning signal is given when milk temperature raises two degrees or when milk temperature drops to 34 degrees. • Built-in automatic washer. 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After Business Hours Phone; Titus Burkholder- 717-859-1620 Paul Repine-717-626-2837 Mervin Nissley • 717-872-4565 Curtis Gassady - 717-62&1065
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