Enforcement Of The

Enforcement actions fall roughly into two categories: actions against products and actions against persons (10).

The Butter Oil Case

In a precedent-setting case, the "butter oil case," decided in 1947, federal agents seized a large quantity of butter because the cream from which it had been made was contaminated with insect and rodent filth. The owner of the butter wished to recoup his losses by making strained butter oil out of the butter. FDA objected to this procedure on the grounds that the resulting butter oil would still contain soluble insect and rodent filth. The court upheld this objection, thus making soluble (invisible) filth just as much an adulterant as particulate (visible) filth (11).

Reconditioning

What the owner of the butter had proposed is a process called reconditioning; by this procedure a substandard product may be brought into compliance if the offending filth in the product is removed. Reconditioning processes are often approved by FDA (12-14).

"Too Small to See" Defense

Another landmark case involved some tomato paste that contained bits and pieces of larval corn earworms (Heli-coverpa zed). The owner of the tomato paste claimed that the insect fragments could not be considered filth—and the consumer would not so perceive them—because the fragments were too small to see. The court rejected that argument (15).

Actions Against Persons: The Park-Acme Case

A series of inspections (1970-1972) of Acme Markets warehouses in Philadelphia and Baltimore resulted in charges against both the company and its president (Mr. Park) for violations of Section 402(a)(4) of the FD&C Act. The president claimed to be innocent on the grounds that the violative acts were committed by subordinates to whom he had delegated authority and that he had no knowledge of or responsibility for the violations. When the Supreme Court decided the case, it vitiated the excuse of "delegation" and determined that top executive officers do indeed bear complete responsibility for violations that occur in their organizations (7,13,16-18).

Filth: "Too Little to Matter"

The bold statements in the two principal filth sections of the FD&C Act would seem to totally preclude the presence of any filth in or around food. The courts, however, have never held to the letter of the law; in other words, there is such a thing as de minimis filth—too little to matter (12,13,15). Some judges have been remarkably lenient in their interpretations of what constitutes significant filth in or around foods, whereas other judges have been less forgiving. In any case, it must be admitted that, without the unconscionable waste of raw food materials, it is impossible to produce foods that are 100% free of filth. The Act, on the other hand, prohibits filth.

Food Defect Action Levels

To bridge the gap between this practical reality and the absolute ban on filthy food called for in the Act, the FDA has established a regulatory tool not mentioned in the FD&C Act, namely, the food defect action levels (DALs) (19,20). The DALs, which apply to about 90 categories of foods, mainly refer to field infestations and other unavoidable contamination. Infestations of stored foods and related insanitary conditions get no relief from the DALs.

The food DALs are administrative guidelines that are set on the basis of no hazard to human health (21). Any products that might be harmful to consumers are acted against on the basis of their hazard to health, whether or not they exceed the action levels. DALs are resorted to because it never has been possible to grow, harvest, and process foods that are totally free of natural defects. Insanitary manufacturing practices will prompt regulatory action whether or not the resulting product is above or below the pertinent DAL.

Recalls

To maintain their good reputations, many food firms are willing to act promptly to initiate a recall to protect both themselves and the public. Even though recalls are not mentioned in the FD&C Act and in spite of the fact that recalls pertaining to food are technically voluntary on the part of industry (10), the FDA can still be instrumental in prompting a recall when circumstances warrant it (7,2224).

Extraneous Matter

The courts have always defined filth in its ordinary sense (ie, the dictionary definition) rather than giving the term a technical meaning (19). The same can be said for extraneous matter, that is, things that do not belong in food such as filth or any foreign matter that comes to be in food as a result of objectional conditions or practices in production, storage, or distribution of food. Included within the meaning of extraneous matter are filth (any objectionable matter contributed by animal contamination such as rodent, insect, or bird matter), decomposed material (decayed tissues due to parasitic or nonparasitic causes), and miscellaneous matter such as sand, soil, glass, rust, or other foreign substances (but not bacteria) (25).

The more common kinds of filth encountered during food inspections and analyses are whole and fragmented insects and mites, mammalian hairs and feces (mostly of rodent origin), feather barbules, urea (from mammalian urine), and uric acid (from avian excretions). Other kinds of filth and extraneous matter include molds and other fungi and weed seeds (26,27).

Light Filth

Since the 1930s the principal method for separating light filth such as rat hairs, feather barbules, and bits of insect exoskeleton from food has been by flotation. When mineral oil is added to a sample of food mixed in water, the oleophilic particles (ie, the light filth) float to the surface while the hydrophilic particles (ie, most foods) settle to the bottom. When the oily portion is passed through filter paper, the filth elements remain on the surface of the paper; the particles of filth are then identified and enumerated by a food analyst (28). Analysts often use reference manuals to assist them in identifying filth elements (26,29-35).

Although flotation methods are still the mainstay of food analysts, other kinds of analytical techniques have been and continue to be developed. These newer methods use biochemical analyses to search out contaminants or indicators of contamination that cannot be detected by direct visual inspection (36-42).

Heavy Filth

Most hard foreign objects (eg, pebbles, sand, glass, pieces of metal or plastic, ball bearings, pits), strictly speaking, are not filth; nevertheless they are often referred to as "heavy filth." These hard foreign objects may be considered adulterants if, when chewed, they cause a gritty mouth-feel (21), or if the particles are large enough or sharp enough to be hazardous to chew or swallow (43,44). The food DALs permit very low levels of natural hard objects (usually pit or shell fragments) in a few kinds of foods (21). When hard foreign objects occur in foods for which there is no applicable DAL, each alleged violation is treated on a case-by-case basis.

MODES OF CONTAMINATION On the Farm

The circumstances by which foods may become adulterated by filth and extraneous matter are legion. The place where the food is grown may be the first source of filth. All field-grown crops are to some degree infested with or affected by insects, mites, rodents, birds, and molds (45). The process of harvesting or gathering the food from the field may inadvertently involve also bringing along live or dead animals, molds, weed seeds, pebbles, and particles of soil. The feces of animals or humans that live in or frequent the field may also be accidentally collected.

This kind of contamination is becoming increasingly important in crops such as lettuce, strawberries, and raspberries that are marketed with minimal after-harvest cleaning (46-48). Foods grown and harvested from aquatic habitats may also be subject to adulteration by a wide array of contaminants (49,50). Foodborne disease outbreaks associated with cross-contamination at retail outlets or in the home are at least as common, or perhaps more common, than outbreaks linked to contamination that occurs where the food is harvested.

In Storage

If the crop is temporarily stored on the farm or placed in longer-term storage off the farm, it may be attacked by insects, mites, molds, rodents, or birds (51,52). These adulterating entities produce mostly surface contamination, but some insects and molds are capable of penetrating food materials and living inside the seeds of beans, corn, wheat, and other crops.

Many kinds of manufactured foods that are stored in warehouses are very susceptible to molds and pests (insects, mites, rodents, birds). Food items stored in metal, glass, or plastic containers are generally safe from the penetrating sorts of infestations or contaminations (eg, urine), but these containers and all other kinds of packaging are susceptible to surface contamination by the urine and feces of rodents and birds. Rats and mice have little difficulty chewing their way into most kinds of plastic, paper, foil, or cloth packaging; some insects also have great penetrating capabilities (53).

In Processing

Standards of sanitation are supposed to be maintained at a high level in food manufacturing facilities, and this is often the case. However, it is difficult under even the best of circumstances to keep all pests out of food processing plants; any laxity of sanitary standards can lead to infestations by pests, and some of these pests may find their way into the foods being manufactured.

In Transportation

Opportunities for pests to infest foods during transport by railcars, trucks, and ships are numerous. The longer the journey in terms of time, the greater the likelihood that pest populations, especially of stored-grain pests (beetles, moths, mites), will dramatically increase.

In Retail

Every retail food outlet (eg, restaurants, grocery stores, sidewalk food stands) is to some extent the target of attack by flies, ants, and cockroaches and rats and mice, too, when the habitat is right for rodent pests. When these insects and rodents come into contact with food or food-contact surfaces, they may add to the food the bacteria and molds that they are carrying around with them. Occasionally a whole insect or rodent fecal pellet becomes entrapped in or falls into the food; the insect body or fecal pellet may remain largely intact or it may be broken up into small pieces as the food material is stirred during preparation. If the insect or fecal pellet had been carrying pathogenic bacteria, the food thus contaminated becomes hazardous to health if it is not subsequently heated to a high enough temperature to kill the pathogens. The Retail Food Code (54) provides guidance to managers on how to prevent food-borne diseases in retail food outlets.

At Home

Homes are no less a target for attack by pests than are retail food outlets. Unlike retail food managers, home occupants are under no legal obligation to keep pests under control. Many householders, if not for sanitary reasons, at least for aesthetic ones, attempt to keep pests under control. Both the obvious pests, such as mice, ants, cockroaches, and flies, and the more cryptic ones, such as stored-food mites, beetles, and moths, are capable of carrying pathogens and spoilage molds and leaving them behind on foods or food-contact surfaces. When homes and restaurants as sources of foodborne illness are compared, the home kitchen is the far more common source. Sanitation in the home kitchen is at least as important as sanitation in the commercial kitchen (55,56).

KEEPING FILTH OUT OF FOOD Integrated Pest Management

Ever since DDT (a pesticide) came to be widely used after World War II, pesticides have been used as the major (sometimes, the only) answer to pest problems. In recent years, a somewhat different approach, integrated pest management (IPM), has come to be applied to pest problems (57-59). The IPM system first identifies the pest, then tries to suppress the pest population by capitalizing on weaknesses in the lifestyle of the pest. IPM may be applied to crops in the field; to stored, raw food grains; to transportation systems; to food facilities of all kinds (eg, warehouses, food factories, groceries, restaurants); and to the home kitchen.

Pesticides may play a greater or lesser role in IPM, depending on local circumstances. The goal of IPM is not to eliminate the use of pesticides (although the trend is in that direction), but to suppress or exclude pest populations (60). This goal requires a comprehensive approach that involves an array of techniques, often including application of pesticides and often emphasizing pest-exclusion practices. IPM merges with and becomes indistinguishable from those aspects of the Hazard Analysis and Critical Control Points (HACCP) system that deal with pest prevention and pest control (61).

For the food-facility manager, pest management is but one link in the chain of food sanitation that begins at the receiving door (62) and ends with the consumer. The important operational guidelines for the manager are to buy only from reliable suppliers, inspect all incoming materials, reject any substandard items, and maintain pest-free premises.

No matter how closely standard cleaning and sanitizing protocols are followed, if pests are tolerated in a food facility, they will inevitably deposit spoilage microorganisms and, occasionally, pathogens on food and food-contact surfaces. A major goal of the food-facility manager must therefore be: zero tolerance for pests. IPM makes it possible to reach this goal.

Hazard Analysis and Critical Control Points

Development of the HACCP system began in the early 1970s. The system has been widely adopted by the worldwide food industry; eventually, it will be mandatory for the entire food industry in the United States. The HACCP system emphasizes the identification, prevention, and elimination of microbiological hazards that could lead to food-borne illnesses (63-67). Extraneous materials such as filth and hard foreign objects do not figure prominently in HACCP, it is true. However, any HACCP program that proposes to be successful must take place in an environment where preventive maintenance protocols and sanitary standards are set at very high levels.

Food-manufacturing protocols often call for a biocidal step such as pasteurization or commercial sterilization that inactivates microorganisms and parasites. Cans or bottles that are aseptically sealed after the biocidal step may still contain hard foreign objects (eg, metal fragments, glass shards) that may be hazardous to health. Foods that go through additional handling after the biocidal step may be exposed to food-contact surfaces contaminated by pests, or the pests may actually come into direct contact with, and sometimes become incorporated into, the food. Such events would be of concern in a HACCP program because the pest may have introduced parasites, pathogens, or spoilage fungi that may proliferate and cause foodborne illness or spoilage of the food material.

Even if very high sanitary standards are maintained in a food-manufacturing facility, those standards will be compromised unless comparable standards extend backward along the food chain to the origin of the food on farms or in aquatic habitats. A system for the protection of the food from adulteration by filth must be in operation at all the steps from farm to table—harvesting, storing, transporting, manufacturing, warehousing, retailing. Defects in sanitation present challenges to the success of the HACCP system wherever it is applied along the food chain.

760 FILTH AND EXTRANEOUS MATTER IN FOOD HOW DOES FILTH IN FOOD AFFECT HUMAN HEALTH? No Effect

If the amount of filth in a food is so small that it falls within the limits set by the DALs, then that filth is assumed to have no adverse effect on human health (21). This conclusion is admittedly an assumption; the fact that this assumption is based on extensive practical experience rather than on scientific experimentation does not make it any less valid.

Indirect Effects

The presence of food-associated pests—insects, mites, rodents, birds—in a food facility is an indicator of unacceptable sanitation practices. The HACCP system works well only when high standards of environmental sanitation are maintained. The presence of food-associated pests compromises the gains in food safety that would otherwise be achieved by the HACCP program in a food facility.

There may be another indirect effect on human health that involves the production of an unhealthy or unstable emotional state when one discovers recognizable insects in or around one's food. This situation may occur anywhere, but it is especially significant if it occurs in a hospital or other patient-care facility when a person already debilitated from injury, illness, surgery, chemotherapy, or advanced age experiences revulsion and loss of appetite upon sighting obvious filth in his or her food.

Direct Effects

The accidental ingestion of insects and mites infesting food may result in the production of antibodies to the proteins of the ingested arthropods (68,69), but this rarely results in overt indications of disease. Matsumoto et al. (70) report on two patients who experienced anaphylaxis after eating foods made from ingredients contaminated with storage mites of a common species, Tyrophagus putrescentiae (the mold mite), and they comment on a third case involving anaphylaxis after ingestion of doughnuts made from ingredients infested by American house dust mites, Derma-tophagoides farinae (71).

The potential for direct physical injury resulting from ingestion of insect-infested food was pointed out in the report of a case of colitis in an infant who had eaten baby cereal infested by dermestid beetles (72).

FILTH IN FOOD IN PERSPECTIVE A Different World

Over the past 30 years or so, some very significant changes have transpired in the area of public health, especially as it relates to foodborne diseases (73). Widespread resistance to antibiotics by pathogens poses a major threat to human health. The population of surgical patients who undergo invasive procedures has burgeoned (such surgeries provide greater opportunities for colonization by pathogens, even some of those that may more usually be associated with food). The number of immunocompromised persons has in creased enormously, not just because of infections by the human immunodeficiency virus, but also because more people are receiving chemotherapy and radiation treatments, and because that portion of the general population considered to be elderly (and therefore more susceptible to infections) is steadily increasing. All of these immunocompromised populations are regarded as being more susceptible to foodborne pathogens and toxins than are immunocompetent persons (74). Some kinds of opportunistic pathogens that never stood a chance of replicating in healthy hosts now find no constraints in immunocompromised hosts.

Emerging Pathogens

The classic foodborne pathogens that have long been known and well studied are quite capable of causing disease in immunocompromised persons and, to a lesser extent, in the immunocompetent. But now there are new pathogens and more virulent strains of classic pathogens to which virtually everyone is susceptible. Not only are the immunocompromised gravely challenged by the newer pathogens, but so also are the immunocompetent. No one is exempt from the threat of foodborne pathogens and toxins. Names and strains that were rarely or never heard of in the 1960s, are now in the news media on a daily basis. Enteropathogenic Escherichia coli, E. coli 0157:H7 (and other highly virulent serotypes of this species), Giardia lamblia, Cryptosporidium parvum, Salmonella typhimu-rium Definitive Type 104, Cyclospora cayetanensis, and others are listed among dangerous emerging pathogens (75,76).

THE PARADOX OF FILTH IN FOOD The Caricature

Some food safety experts and even at least one government have taken the position that looking for filth in food is simply not worth the required effort and expense. The small benefit to the public gained from occasionally finding a food item that is disgustingly filthy cannot, they contend, justify the expenditure of the time and money needed to make that discovery. To justify this position, these experts make a caricature of people's aversion to filth in food—according to them, everyone in a lifetime is going to "eat a peck of dirt" and, besides, it is harmless anyway. Apparently, even in this camp of experts there is still some interest in the maintenance of sanitation around food, if not in food, and that position continues to yield modest benefits to the consumer.

The Promise

The position just described reflects a misunderstanding of the significance of filth in food, especially if the filth was added to the food after the final biocidal step in food processing. The occasional rat hair that is extracted from a food sample probably does not represent the shedding of a single hair from a rat moving about above a food processing line. More likely that single rat hair represents two things—it is probably just one of a much larger number of hairs, most of which escaped detection; and it more probably represents a remnant of a fecal pellet, now disintegrated and dispersed throughout the food material.

When rats and mice groom themselves or each other, they remove and swallow hairs which then become incorporated into the feces of the rodent. Such pellets are never sterile, but only a small percentage of them carry pathogens that cause human disease. But some do, and here is where risk enters the picture, especially if the contamination occurs after the last biocidal step in processing and especially if the consumer of the food is immunocompromised.

What is said of the rat hair can be said in principle of all the filth elements that make their way into food—they all carry spoilage organisms, some of them carry pathogens, rarely do they emerge intact from the food production line, they are all more dangerous if they enter the food manufacturing process after the last biocidal step, and their danger to human health is related to the virulence of any pathogens they might carry and to the susceptibility status of the consuming host.

It is admirable for food safety monitors to say that action will be taken against a food manufacturer or ware-houser or retailer if food pests or filthy conditions are found in a food facility, but it makes no sense to suggest that food emerging from that facility does not need to be examined for filth. The experience of countless food safety inspectors and food analysts testifies to the fact that food emerging from a filthy, pest-infested facility will bear filth far above the standard action levels and stands a good chance of becoming associated with a foodborne disease outbreak (77-79).

Early Warning

The analysis of food for adulteration by filth may serve as an early warning of lapses in sanitary protocols in the food facility and the nearly inevitable associated compromise of the HACCP program. Examination of food for light filth is a rapid, cost-effective, and efficient way to evaluate the status of sanitation in a food facility. This kind of ongoing quality assurance program gives the consumer confidence that the food as it leaves the production line is safe for consumption by virtually all persons, regardless of physical or emotional health, except for the small percentage of the population that suffers from specific food allergies. In view of the widespread occurrence of newly emerging, highly virulent pathogens, a laissez faire attitude toward filth in food is no longer tenable.

The reader may find a more detailed discussion of this topic in the first edition of this encyclopedia (80).

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