EXCERPT FROM MARCH 1980 MARSH & MCLENNAN PUBLIC OPINION SURVEY FEELINGS ABOUT THE JOB DONE BY VARIOUS Q: Here is a list of some government regulatory agencies concerned with public health, safety, and CHEMICAL CONTAMINATION Mr. WHITTEN. You state that in the last 20 years your concerns have shifted from preventing gross contamination to potentially more dangerous situations regarding small amounts of substances that may be highly toxic, and you point out that your tasks have become much more complex because analytical chemistry can detect very low levels of test substances. What evidence can you cite to indicate that the problem of chemical residues is really : growing, as opposed to the possibility that you are just looking closer now and merely identifying things that were not serious enough to be considered problems before? Dr. NOVITCH. It would be simple to compare today's residue findings with those obtained 10 or 20 years ago-the comparison would reveal that FDA presently detects many more residues and can measure them at lower levels than in the past. However, this might easily be attributed to the use of more sophisticated analytical methodology. To be sure, advances in analytical chemistry have enabled the Agency to identify many previously unrecognized contaminants. But we must also realize that in the last 20 years, many billions of pounds of chemicals, many of which are extremely toxic and resistent to degradation, have been produced and marketed. Corrective measures to control the release of contaminants to the environment have only recently been attempted. For many decades, chemical wastes of many sorts have been indiscriminately discharged, buried in landfills or simply dumped. Also, before the dangers of many pesticides were fully realized, run-off of these chemicals polluted our waterways. Over time, these chemicals have entered aquifers and surface waters, and have built up in sediments. For these reasons we believe that the problem of chemical residues in the environment and in foods has grown tremendously. We believe that we are just beginning to observe the cumulative effects of this process. As control measures become more effective, the problems can be expected to diminish, but it may be another 10 or 20 years before conclusive evidence can be obtained. Regarding the identification of things not known to be serious enough to be considered problems before, the scientific community has only in recent years become aware of the insidious effects of minute quantities of a wide variety of chemicals. Some chemicals are now known to produce deleterious effects as part per trillion levels and less, such as dioxins. As our knowledge of toxicology has grown, we have had to expand our analytical capabilities because of the need to determine lower levels and a wider variety of food contaminants. The additive effects of myriad residues are generally unknown, so we are in the position of controlling those residues we know to be harmful as best we can. It is likely that the scientific and medical community will continue to refine and improve our knowledge of the potential effects and interactions of the chemicals in use. Overall, I would say that it is not our testing capability that gives rise to this concern, but increased use of chemicals in our society over the last 20 to 30 years, coupled with the improved knowledge of toxicology, and particularly the well-known incidents such as the Love Canal and the PCB and PBB contamination incidents. Some of the chemicals we are concerned with have come into use in more recent years and thus represent new problems, but some have been around for a number of years. For example, PCBs have been in use for fifty years, but only recently have been found to represent a serious health risk. This risk has existed for many years, and we simply were not aware of it. Mr. WHITTEN. Through your programs we are learning more about trends in chemical residues, but are we learning anything more about human health effects of these residues? Dr. NOVITCH. The potential health effects of chemical residues or contaminants are actively being studied by the scientific community. This work is being performed by laboratories in the government, academia, and the private sector, not only in this country, but abroad. For instance, FDA is currently sponsoring, in conjunction with the Health and Welfare Department of Canada, a study of the effects of polychlorinated biphenyls, or PCBs, on reproduction and neonatal viability of primates. Although much of this work involves studies with laboratory animals, there are a number of human epidemiological studies which have been and are being conducted. For example, studies are continuing on the residents of Seveso, Italy, who were accidentally exposed to dioxin. The body of knowledge on the health effects of chemical contaminants is constantly growing. As new information is generated, scientists within the Agency are assessing these developments in relationship to human health and food safety. In addition to measuring trends and analyzing the usage of potential contaminants, the increasing knowledge of health effects is an essential part of our own direction of resources toward the most significant risks. FSQS BUDGET INCREASE Mr. WHITTEN. The Food Safety and Quality Service was here yesterday. They are one of the very few Federal agencies to have a requested increase survive the recent round of budget revision. Their revised budget includes an increase of $8.2 million in 1982 for the control of chemical residues. What was the history of your budget request for 1982 for the control of chemical residues, and what are your thoughts on the fact that the FSQS request was approved by both the old Administration and the new Administration, but yours was not? Dr. NOVITCH. Our initial request to the Public Health Service for fiscal year 1982 included an increase of $11.2 million for Food Safety programs, which was almost entirely for the Chemical Contaminants program. Our request to the Department included an increase of $9.4 million for this program, and our request to OMB included $6.7 million for this program. As you know of course, our original fiscal year 1982 request to the Congress included no program increases. I would not be able to speculate on the reasons as to why OMB allowed an increase for FSQS, particularly since at OMB the USDA budget is analyzed by a different division from the one that reviews our requests. The only comment I could offer is that, if the FSQS increase were granted, it would be indirectly helpful to us, since our concerns in this program area are similar, although we have distinct responsibilities. 77-302 (Pt. 4A) 0-81- -4 TOXICITY IN NATURALLY PRODUCED FOODS Mr. WHITTEN. You state that there are many widely used, naturally produced foods which contain substances that you know can be injurious to health for some people, and which could not be removed without major changes in the make-up of the food supply. Please give several examples of such foods and such substances beyond the examples presented by caffeine and nitrite. Dr. NOVITCH. I can provide a few examples, although this is a very complex situation. Many substances have the potential for harm to some individuals at some level of exposure. Consider, for example, the effects of sodium chloride, a substance common to most foods, on some individuals, or the fact that food allergens, many as yet unidentified, cause extreme hardship to a small percentage of the population. In addition many naturally occurring toxic components of foods are inactivated during normal cooking or processing of foods. For example, the cyanogenic glycosides present in raw lima beans, if ingested, lead to particularly severe cyanosis, but cooking inactivates the enzyme, preventing release of cyanide and thus preventing occurrence of the acute toxic reaction to cyanide. Many other foods contain cyanogenic glycosides in varying amounts, and the human health problems associated with ingestion of such foods, when not properly prepared, have been documented but not quantified. The list of known, acutely toxic substances in foods is seemingly endless-oxalic acid in rhubarb and spinach, ipomeamarone in sweet potatoes, glycoalkaloids in white potatoes, and so on. Most of these compounds we have learned by experience to handle either by proper food preparation or by limiting the quantity ingested. Å much more difficult problem is associated with evaluation of the risk incurred on ingestion of compounds exhibiting sub-acute toxicity, such as carcinogenicity, teratogenicity, or mutagenicity. such is the case for many mycotoxins, including aflatoxin, the pyrrolizidine alkaloids in herbal teas, and myristicin in nutmeg and carrots. The research to date has implicated each of these cases in health related problems, each has been identified in common foods, and each deserves attention. Lest one get the impression that natural toxins are confined to the vegetable kingdom, let me call your attention to the severe health problems arising from the ingestion of seafoods, specifically paralytic shellfish poisoning from shellfish, and ciguatera poisoning from ingestion of reef fish. In both cases, as is becoming increasingly apparent, large numbers of individuals are affected each year, and large economic losses accrue to the seafood industry. Nor are dairy products an exception. To a large portion of our population who are unable to digest lactose, this component of milk can cause a considerable amount of distress. In some cheeses, it is not uncommon to find levels of the vasoactive amines, histamine or tyramine, sufficiently high to affect adversely a large proportion of the exposed individuals. Levels of these amines can at times be sufficiently high to be life-threatening to those on medication that suppresses monoamine oxidases, the enzyme that would normally convert these amines to inactive compounds. These are a few of the foods with specific types of toxicity, not to mention more general and complex questions such as cholesterol. As I mentioned, society has learned to deal with many of these foods by proper processing and preparation, and individuals sometimes learn to avoid foods that affect them, when they are able to identify the particular food. We can attempt to deal with some toxins such as aflatoxin and the shellfish poisons, but in many cases we could not eliminate a health risk to some of the population without banning whole categories of common foods. INSPECTION AT FEDERAL BUILDING 8 Mr. WHITTEN. You state that you must base your action, or your refusal to act, on "scientific data produced under research conditions that reasonable scientists would accept as reflecting the best available methodology." You also state, "In order for FDA to stay abreast of these advancements, we must maintain an effective combination of both scientific talent and contemporary scientific facilities." In the past, the primary criticism of FDA in this regard was the physical condition of its animal testing laboratories. We are in the process of correcting that problem. Now we understand that an inspection conducted last September, jointly by scientists from the Baltimore District Office and the Bureau of Veterinary Medicine, has detailed numerous procedural violations in the conduct of the non-clinical studies conducted at the Bureau of Foods. Please provide for the record a copy of the Bureau of Foods' response to this report. Dr. NOVITCH. The scientific evaluation of the inspection report has not been completed. A number of the deviations are either directly or indirectly related to the facility. However, we are taking measures to correct the deviations, even though we are not sure that they will have a negative impact on our non-clinical studies. We have also established two committees in the Bureau of Foods to work on the immediate as well as the long-range solutions to the problem. One committee is assessing the caffeine study, and the other committee is developing a program of activities to bring the laboratories into full compliance with the regulations. I will be happy to provide for the record a copy of the Bureau's response which lists the inspector's observations and their com ments. (The information follows:] |