Document EdDp68Rq5JoODx964MvR0K12x

PETER II. SCHUCK "I'd hate everybody to Hart worrying about the eggs they cat." 'Plus comment to the press by a spokesman for the Pood and Drug Administration, made after learning that FDA had permitted more than 60,000 rggi contaminated with a DDT-like toxic chemical to be consumed by the public, speaks volumes about the Government's protection of the food supply. Nine months later, still another such "accident," necessitat ing the destruction of more titan 1.2 million chickens, confirms that food consumers remain at the ntcrcy of the fertile creativity of the chemical industry. According to the President's Council on Environ mental Quality, several thousand new chemical com pounds arc discovered each year, of which several hun dred are annually introduced into commercial use. Many of these arc intended for use as food additives. Many, however, arc poisons expressly prohibited by law front coming into contact with huntans, much less entering the food supply. Polychlorinated biphenyls (commonly known as PCBs) arc compounds of the poisonous variety. FDA requires that meat or fish contain PCD residues no more than five parts per million (ppm) and that eggs have no more than 0.5 ppm. PCBs possess toxicological, chemical, and environmental properties strikingly sim ilar to DOT. lit fact, the com)>ounds arc so similar dial much of the environmental damage attributed in the past to DDT is now thought to have been caused by PCBs. The Monsanto Company, a giant chemical firm, is the sole domestic manufacturer of PCBs (under the name Aroclor). They arc used widely as industrial chemicals in heat absorption and plasticizing processes, principally in heat transfer units, electric transformers, and die like. Like DDT and many other chlorinated hydrocarbons, Peter //. Sehuck it a senior staff member of Ralph Xader'j Center for Study of Retpontive vv. Before joining the Center, he attended Cornell University and Harvard Law School, practiced law for three years, and taught at Harvard, PCBs are extremely persistent, pervasive, and toxic substances. They degrade even more slowly than DDT, and arc water insoluble and fat soluble. Thus, PCBs accumulate and concentrate in the body's fatty tissues. In addition to (and in part because of) their sta bility, PCBs are found virtually everywhere in the ecosystem. In 1070, PCB levels in fish near England were found as high as 900 parts per million--"the high est concentration of poisonous industrial chemicals ever found in wildlife," according to a British government study. One researcher reports that in Arctic lakes, rare ly if ever visited by man, all of the fish analyzed contained measurable amounts of PCB; one lake trout had twelve ppm in its fat. Conccmiaiiuiis of up to 600 ppm have been found in human tissues. And ran dom samples of milk from nursing mothers in Califor nia averaged higher than two ppm. The incomplete scientific evidence on PCBs sug gests that they constitute a significant human health hazard. Since PCBs were first recognized as an environ mental problem only in 1966, and since the meth odology for distinguishing PCBs from DDT and other chlorinated hydrocarbons has been developed only in the last few years, scientific data on the nature and extent of PCB toxicity for huntans is necessarily quite limited. The presailing view among PCB researchers, however, is that the chemical can affect liver detoxifica tion activity, enzymatic processes, and other basic biological functions. Back in 1912, all 100 men in continual work contact with PCBs in one plant contracted chloracnc, a skin disease. Cases of yellow liver atrophy in humans have also been attributed to PCBs. lit 1968, cooking oil con taminated with PCBs caused an outbreak of skin disease affecting more than 300 people in Japan, in cluding nine pregnant women. Some of the women miscarried, and al( (including (he babies) showed and continue to show symptoms of chlorobiphcnyl poison ing. According to the rough calculations of Dr. Robert Rjscbrough, a PCB expert at Berkeley, consumption of forty-five pounds of fish and/or poultry contaminated May, 1972 23 nQHS 069854 with PCBs at the FDA-approved level of five ppm might produce the effects observed In Japan. There is evidence that the toxicity of PCB formulations may in fact be attrihutnblc to the presence of contaminants (called dibrnzofutans) similar to and only slightly less toxic than the contaminants (called dioxins\ oF 2,4,5-T, die herbicide widely used in Vietnam (under the name Agent Orange) and cancelled for use on food crops in the United States. were dosed off. rcrhnps most important, the public wu kept in the dark. These and other regulatory failures by the food agencies are not simply the consequences of limited resources. For fiscal 1972, Congress appropriated $6 million more for meat and poultry inspection than. USDA requested. Congress has, in recent yean, also tended to give FDA at least ns much as FDA requests for food inspection activities. One's answer to the key question--how much money is "enough"?--in large part depends on the manner in which the agenciea view and discharge their public trusts. There has been no lack of warnings about the human hazards associated with the widespread industrial use of PCDs. In April, 1970, Representative William F. Ryan, New York Democrat, called on FDA to set formal food tolerance levels for PCBt and convene an interdepartmental task force to study the problem. Ryan has also introduced legislation to ban PCBs until Monsanto can prove their safety. Yet FDA has never established a forma) tolerance for PCBs in food. After several incidents of massive PCB contamination of the food supply, FDA finally set an arbitrary, temporary "action level" of five ppm in flesh and 0.5 ppm in eggs, below which PCB residues were deemed "safe." Between April 30 and mid-July of 1971, PCBt used as heat transfer fluid leaked into fishmeal produced at a North Carolina plant. The meal was sold to sixty* five companies in twelve states for use, among other things, as an ingredient in feed for chickens, turkeys, hogs, and catfish. When Holly Farms, the nation's largest producer of broiler chickens, discovered in June that flocks fed this feed showed mortality about seven times the normal rate, I'DA (responsible for inspection of shell eggs) and the U.S. Department of Agriculture (responsible for inspection of meat, poultry, and egg products) found themselves with a full-scale food crisis on their hands. In the ensuing weeks, these agencies condemned many tons of fishmeal, more than 165,000 broilers, 250,000 pounds of turkeys, hundreds of thou* sands of eggs, several hundred thousand pounds of egg products, a thousand tons of catfish feed, and other assorted foodstuffs. 'This flurry of activity prompted many press releases by these agenda and Monsanto, congratulating themselves on their unremitting pro* lection of the consumer and assuring him of the com* plclc whoicsomcncss of lils food. Neither the sclf*praisc nor the assurances were justi fied; indeed, quite the reverse was the ease. The agen* cics were slow in gearing up their systems for sampling products exposed to contamination, and these sampling systems were generally not adequate for contaminations of this magnitude. 'The peculiar division of inspection responsibilities was exacerbated by a striking lack of coonlinuliun among the agencies. For example, FDA never furnished USDA wit!) a list of the subcontract* ccs of the sixty-five firms which purchased the contam inated meal; thus USDA could never ensure that all possible sources of contamination of meat and poultry These failures, then, are really symptomatic of a more fundamental problem--the regulatory philosophy which scorns to pervade the food agencies. Judging from the incident of the PCB-contaminated fish meal, one can identify three elements of this philosophy --the reasonable risk principle, the secrecy principle^ and the mindless public principle. Throughout this incident, (he food agencies bom barded the public with assertions that since absolute safety was an impossible goal, reasonable risks must bo taken if society is .to reap the benefits of PCB use. Standing by themselves, such assertions are unexcep tionable--benefits and costs must of course always be weighed. In the case of environmental chemicals like PCBs, however, FDA's assurances are presumptuous and misleading. As Dr. Samuel Epstein of Case West ern Reserve Medical School has testified: "When one talks about matching benefits against hazards, that im plies that you have a clear concept of what the hazards are and a clear copccpt of what the benefits are. In the absence of such information is it possible to deliver .a reasoned analysis on the way these factors match?** While the industrial benefits of PCBs have been iden tified, there has been no showing that a nonhaznrdous alternative of equal or greater efficacy does not exist or could not be developed. And, as we have seen, (lie cost side is uncertain at best, with some evidence of long-term food hazards all along the food chain. What ever result a comprehensive benefit-cost analysis might yield, it is quite clear that FDA has not conducted such an analysis. Quite the contrary. According to Dr. Risebrough, the five ppm figure "is just a number. I'm sure FDA pulled it out of the air," Some other toxicol ogists inside FDA agree. And recent events strongly suggest that FDA docs not even enforce these levels with any seriousness. The agencies' adherence to the reasonable risk prin ciple might explain what otherwise seems inexplicable --the toleration of any levels above a trace of this toxic substance in the food supply. Yet the explanation given by a deputy associate commissioner of FDA to an inter agency meeting of scientists makes one wonder how principled and considered this toleration is: "1 think 1 will start off by giving the FDA regulatory policy on PCBs in foods. It is a very simple one: we do not approve of any foods containing PCBs, nor do we condone any practices which result in any levels of PCB residues in foods. 24 .. MGNS THE PROGRESSIVE 069855 "tt'liito llw< may be our policy, until there a ? '.v.dly sanction H u??s, wc hive been forced to corr1,,,omi*c tli.it policy to the extent th.it we do not i.Itji'ct to the marketing of certain >ecific V ts of food ihat might contain some low levels of PCBs. I do want u* iticu the difference Ijc tween approving and not objecting to. I think this is the key." FDA'* permissiveness was fortified when Monsanto, .dter another earlier PCB scare, agreed to market PCBs i.nly for "dosed system" uses, that is, uses not leading to human exposure. Yet this theory crumbles under scrutiny. First, Monsanto does not amt cannot control the use# to which its purchasers put PCBs; it can suggest but it cannot coerce. Second, until recently, and despite almost two years of constant prodding by Repre sentative Ryan, Monsanto arrogantly and persistently refused to disclose any of its PCB sales data to the Government, regarding such data as "extremely confi dential" (although it lias no domestic competitors for the product!. Thus, there was no way for anyone else, Including the Government, to enforce this limitation or evaluate the hazard to the public. At least as recently as last June, PCBs were being widely employed in "open system*' use, as a constituent of carbonless carbon paper and as an ingredient of much recycled paper, at levels up to 30,000 ppm. Only in September did the public learn that FDA had known this since June. Finally, a truly "closed" sys tem is about ns rare a phenomenon in modem life as truly clean air. Significantly, all known incidents of 1*CB coniamhuiliun of food have resulted from sorailed `Vlosctl system" uses, such as in industrial plants, plastic packaging, silo linings, and heat transfer units. A fundamental objection to the reasonable risk prin ciple, as implemented by the food agencies, is that it is constantly tlmarled and nullified by a competing dog ma--the secrecy principle. If reasonable risks must be taken, then the public and Congress arc entitled to participate in the judg ments as to what risks arc reasonable, what level of safety the public is willing to pay for, and what pri orities arc to be served. The agencies' passion for srtre- ry, however, precludes such public inputs by denying the public information neccssaiy to making such judg ments. The PCB incidents abound with instances of this secrecy. An egregious case occurred in August when FDA took samples from a suspect shipment of 60,000 eggs in North Cuiotina, releasing the shipment for trucking to a Washington, distributor. I nc days later, when FOA completed its analysis of the sample, it found PCD levels in (he sample of four to five ti/ucs the permissible concentration. FDA went to the distributor's warehouse, only to learn that the eges had been sold to Washing ton area restaurants several days earlier. At this point, FDA threw up its hands and went on to other things. FDA not only failed to make any effort to alert consumers to (he danger so that (hey could destroy those contaminated eggs not yet consumed. It also threw a cloak of secrecy over the incident. ' __The matter becan j pub. only when an oy*i :e mvestirat'-r 'caked it u>~tKv"F"esi"'r .ore than a week later. FDA, asked by tF > press lo explain r s p*.fomancc, proceeded to undermine the integrity of iu owu "action level," established in light of tlv chronic tox icity of PCBs, their concentration in human tissues, and their ubiquity in the ecosystem. One FDA spokes man told the press, ``That much PCB is like a drop in a tank car." Another insisted that there was no real health problem because of the short term exposure. "Fd hate everybody to start worrying about the egg* they cat." Unfortunately, this was not an isolated example of the secrecy principle in action. On August 12, 1971, outside investigators learned that twenty of the first fifty-six egg samples tested by FDA throughout the southeast producing areas had contained excessive lev els of PCBs and that this had been known by FDA for more than a week. Again FDA failed to make it* findings public, despite FDA's knowledge that 60,000 tainted eggs had already reached consumers, and de spite the distinct possibility that other contaminated eggs were likewise reaching consumers. Again, only news stories following a leak tp the press induced FDA to issue a belated press release. USDA also honors the secrecy principle. USDA, on August 12, discovered in turkeys the highest PCB level* theretofore found in meat or poultry product* en rout* to the consumer market: 11.83 ppm in total edible tissues. Although USDA detained 250,000 pound* of turkeys as a result, it failed to make this matter public until it wos obliged to respond by letter to inquiries made by Senator Ccorgc McGovern. On August 26, the day of its letter to McGovern, it finally issued a news release. These instances of non-disclosure--when they are ultimately brought to light--erode public confidence in food inspection agencies. Perhaps more important, these agencies, by inhibiting the public and Congress from learning of the magnitude of the threat of chem ical contamination of (lie environment, weaken the inclination of the public to press for changes in public policy concerning food inspection and toxic substances. Supplementing and legitimizing the reasonable risk and secrecy principles is the mindless public principle. FDA Commissioner Charles F^dwards elucidated this principle with admirable clarity in testimony before the Senate Appropriations Committee on May 13, 1971. After speaking of the "far more sophisticated consumer today," a consumer who is far more knowledgeable about scientific theory and techniques, who "want* more information about the product he buys," Dr. Ed wards continued: "We can't caution the public that there might be something wrong with a product in rare instance* or that use of a product should be restricted, because My, 1972 , 25 HONS 069856 public rraction i always an ov% .action; the pendu lum swine* 100 far in most cases, ami consumers lend to boycott a product if any doubts have been raised about it, even (ltoui*ls we might feel that continued use within certain limits is entirely justified.'1 (Dr. Ed wards' emphasis.) Is the ``far more sophisticated consumer today" really so juindlet'? Consider the rerent discovery of botulism in a small number of cans of Campbell's chicken veg etable soup, and the publicized recall of the soup. Snicly, in xiew of the widely publicized death and paralysis of a man and wife from Hon Vivant soup last summer, tins is an excellent ease with which to test Dr. Edwards' thesis that "public reaction is always an ottff-rcaction." Arcording to The j\'ew York Times of August 25, however, the public reacted with great circiunsjKTtion. A sj>ot check in some fifteen cities icvcaled that consumers were taking the ensis calmly, that the public disclosure of the recall had little effect on soup sales. Some shopj>crs made inquiries of their grocers and "a few wary" ones returned cans of Campbell's chicken vegetable soup, but calm was the prevailing rcqwnsc. A food inspection agency cannot justifiably fail to make full a:.d timely disdosoic about the quality of the food supply on ihr ground (hat an informed public will always over-react. Our system prcsup|>oscs (hat, within broad limits, it is for the consumer to decide for himself on the basis of full information what he will and will not eat, and what risks he will and will not take. Nor is there justification for failing to inform fully the consumer oit the ground that the danger to the public is not yet conclusively proved. When dealing with the imegiity of the food supply, agencies cannot net on mere rumor, to be sure, but neither in most cases can they afford to wail until all the evidence is in. Of necessity, (hey must often net on the basis of incomplete information and disclose that fact to the consumer. The burden of any uncertainty must not fall on the consumer. The food ins|>cction laws did not in tend that he be made a guinea pig simply because we live in an uncertain world. It is imjX'rtant to bear in mind that the regulatory philosophy implicit in the reasonable risk, secrecy, and mindless public piinciplcs could not flourish if the administrators of the food agencies were subjected to a truly pluralistic array of pressures in their day-to-day decision-making processes. They are not. The pressures --in the forms of information, the claims of personal tics, rclcntlos lobbying, campaign contributions, ami other instruments of persuasion--arc virtually all from producer and marketing groups. Input from consumers is sporadic and poorly financed. The existence of "ad vocacy gap*' has been documented for both USDA And l`*DA by recent Nader rrjjorts on those agencies {Sowing (he Wind by Harrison Wollford and The Chemical Feast by James S. Turner). Since the Washington, D.C., contaminated eggs inci dent, several new "isolated occurrences" (in USDAs phrase) of PCB contamination of food have come to light. In Minneso' >0,000 turkeys, come ninated at levels ns high as thuiy-five ppm in edible tissue, were processed by a subsidiary of Swift & Co., the world's largest meat packer. Swift's identity was concealed by high USDA officials "in the best interests of consumers" and "because the situation now is under control.'* Yet many mouths later, the source of contamination re mains a mystery. Nevertheless, USDA tested these tur keys to see if they could be "cooked out" until the PCI! levels fell below five ppin, at which point they could be salvaged and marketed (or use in frozen din ners, pot pics, and soups. Swift & Co., apparently more sensitive than USDA to the cpsuing outcry, subsequent ly announced that the turkeys would be destroyed after all. Subsequent events arc even more ominous. Excessive PCB residues have now been found in many food packaging materials, raising the specter of PCB migra tion from such packaging to the food itself. And the preliminary results of a Cornell study of ring doves fed PCBs found that no ill effects in the first gener ation were followed by heavy embryonic mortality in the second, suggesting (in the researcher's words) that "the current interim guideline of five ppm does not have the margin of safety that earlier single-generation studies had suggested." If one looks diligently, very diligently, for a hopeful portent in all of this, there is one possible solace. Evidently, FDA and USDA can learn from their mis takes after all--at least if those mistakes recur often enough. In mid-February, yet another "isolated" PCB emergency was made public, this time in Maine. The magnitude of this latest contamination is truly stagger ing. In late March, with more poultry being condemned every day, USDA had already destroyed a total of 1.25 million broilers and roasters--over four million pounds of poultry. The initial response from the food agencies was that no more than 250,000 birds could possibly be contaminated, that they had identified the source of contamination, and that everything was under control. They now concede, however, that they know neither the source nor the extent of contamination, and that they cannot be certain that none reached con sumers. In a classic case of too little too late, FDA has finally proposed regulations to ban the use of PCBs in feed mills, food.processing establishments, and in food packaging facilities, a proposal that FDA was supposed to have implemented many months ago, long before the Maine incident. While this is a small step forward, to be sure, this proposal will not affect PCB contamination of the food chain from other sources, nor will it affect FDA's liberal tolerances of PCBs in foods. At a press conference called by FDA Commissioner Edwards to reassure the public about PCBs, Edwards insisted that "an outright ban is not feasible and would not be in the best intcicst of the consumer." He was visibly shaken when informed by a member of the press that a limitation on PCBs had been in effect in England for some time. 26 THE PROGRESSIVE HONS 069857