Boston — IS the government satisfactorily performing its task of protecting such vital resources as food? A recent report by the US House Government Operations Committee took sharp aim at that question, charging the Food and Drug Administration with inadequately monitoring the safety of the nation's food supply. The report, ``Human Food Safety and the Regulation of Animal Drugs,'' dealt largely with the FDA's record in approving drugs given to livestock and poultry, traces of which show up in meats and other animal-derived foodstuffs.
Using the controversy over the FDA's regulation of animal drugs as a basis for discussion, the Monitor gathered several perspectives -- from the governmental, consumer, and scientific sectors -- on that key question. What the report said
The Government Operations Committee report charges the FDA with failing to test and approve 90 percent of the drugs given to animals by farmers and veterinarians -- some 20,000 individual products. This failure violates federal law, it asserts. As many as 4,000 of those substances, the report states, could present hazards to human health if they turn up as residues in meat and other products.
The document also raised doubts about the safety of many of the drugs that the agency had approved in the past, pointing out that they were approved under previous standards less stringent than those now in force. While noting that the FDA may have staff shortages that hinder its ability to do the testing and monitoring needed, the report indicated that the agency has tended to bow before pressures from manufacturers and users of the animal drugs, both with regard to getting new drugs on the market and taking old ones off.
Those involved in preparing the report emphasize that many of their figures came from FDA sources themselves, and that the report had unanimous bipartisan support. Government agencies defend their roles
Dr. Richard Carnevale, deputy director of new animal drug evaluation at the FDA, argues that the figure of 90 percent of animal drugs being unapproved is overblown. It ``lumps together'' a lot of similar chemical products that are on the market in multiple forms and dosages, he says, but that are ``one drug in the generic sense.''
Still other items in the overall figure, he says, are likely to be drugs given to animals that aren't used for food. Given agency resources and the large number of drugs in circulation, the FDA has to concentrate ``on fairly potent prescription items -- those used in a large number of animals and used frequently,'' says Dr. Carnevale, who has been with the agency for 10 years.
In the ``real world,'' he says, compliance with the ``letter of the law'' -- complete testing of every drug on the market -- would be ``virtually impossible.'' He explains that unapproved animal drugs sometimes have ``interim market status,'' but that this is granted only to items judged unlikely to be considered carcinogenic.
With regard to drugs approved in the past, the FDA has what it calls ``causal review'' -- meaning that if evidence comes up that the drug is ineffective or dangerous, it will be looked at again. On average, the agency has conducted two such reviews annually in recent years, and all of those, says Carnevale, arose over questions of efficacy, not health danger. ``We use enough conservatism around here that when drugs are approved [allowed on the market] . . . consumers are probably adequately protected,'' he observes.
What about industry pressure? It exists to a degree, says Dr. Carnevale. But the agency's record of approving only 13 new drugs since 1982 shows that the process is not being speeded up to appease industry, in his view.
The US Department of Agriculture comes into the picture as animals are slaughtered. The USDA ``routinely'' monitors meat production for residues of ``100 or more'' chemicals, says Nancy Robinson of the department's Food Safety and Inspection Service. She says that the department tests ``at a level that we think can assure detection of chemicals.'' The USDA works closely with the FDA, she says, to develop analytical methods for better detection of drugs and to set priorities on the kinds of drugs that most need monitoring.
What about possible misuse of animal drugs by farmers? The best check on that, says Ms. Robinson, is the drug labeling information required by the FDA. Beyond that, the USDA sometimes focuses on a particular problem. Currently, she says, the department is working with producers of pork to bring down the level of sulfa drugs, used against bacterial infections. Scientist says testing is difficult
Lee Shull, an environmental toxicologist at the University of California at Davis, emphasizes the technological difficulties in testing for residues of all veterinarian drugs heading toward the marketplace. Different drugs demand different testing methods, says Dr. Shull, who has worked with the FDA to develop better methods of analyzing residues.
For some drugs, methods exist to measure ``very minute amounts,'' he explains. One problem, in his view, is the assumption that ``if we can measure parts per billion in some things we should be able to do it for everything.'' That, he says, ``is simply not so.''
Also false, says Shull, is the perception ``that if the chemical is there, it's per se harmful.'' Many of the things people may expose themselves to daily are relatively more harmful than residues of animal drugs in meat, he says, using as an example some of the ingredients in coffee. He advises caution in the use of the word ``toxic,'' pointing out that the term evokes images of things like snake venom. Often, a term like ``foreign substance'' might be more accurate than ``toxic,'' he argues. Amount is ``all important,'' he continues, citing the maxim, ``dose determines poison.'' In fact, he says, veterinarian drugs ``are relatively harmless as best we know.''
Overall, given the amount of monitoring now being done compared with the past, he suspects the US food supply is probably safer now than it's ever been. Still, he concedes that ``there probably are substances showing up in meats that shouldn't be there.'' The basic reason for this, he says, is lack of personnel at the FDA. Testing for a single drug, including arriving at acceptable tolerances and accurate measurements of residues, is a long process. ``Generally,'' Shull says, ``one to three people are dealing with several chemicals at one time.'' And when it comes to testing for ``metabolites,'' the changed forms a drug assumes once it's been eaten and absorbed by an animal, the task gets even more complex, he notes.
What it boils down to, in his view, is that if the public really wants absolute assurance about levels of safety in these matters, ``they're going to have to put their money where their mouth is and expand hundreds of times the testing that is done.'' Consumer groups see `gaps' in protection
Pat Kelly, director of communication for Public Voice for Food and Health, an affiliate of the Consumer Federation of America, praises the Government Operations Committee report for again highlighting ``gaps in governmental protection'' of the food supply.
She asserts that it is a problem of long standing and refers to a 1976 Government Accounting Office study that found 14 percent of all meat and poultry to contain drug and chemical residues that violated federally established tolerance levels. That figure was based on tolerance levels in effect almost a decade ago, she points out. Today's stricter standards could mean an even higher percentage of affected foods, in her view. Federal agencies charged with inspecting these foods have not been ``keeping up,'' she says.
The USDA's residue monitoring program has been gradually weakened since its beginning in 1980, asserts Ms. Kelly. She criticizes what she sees as a growing emphasis on educating producers on the use of drugs, rather than ``control, actual sampling'' of meats for residues. The department is currently testing for ``less than 50 percent of the chemicals expected to leave residues,'' she says. The ``best control'' we have over the residue problem are the tolerance levels set by the FDA, Ms. Kelly continues. The crucial need, from her perspective, is for thorough ``enforcement and inspection.'' At present, she says, ``the whole chain of consumer protection is riddled with holes the whole way down.''
Should foods be labeled to warn consumers of possibly harmful drug residues? Her organization is against labeling ``at this point,'' Kelly says. ``Let's just enforce the law concerning regulation.''