American Journal of Law & Medicine

If FDA Does Not Regulate Food, Who Will? A Study of Hormones and Antibiotics in Meat Production

I. INTRODUCTION

Approximately 128,000 Americans are hospitalized and 3000 die each year from foodborne illness. (1) A ten-year study of 4589 foodborne outbreaks attributed 46% of these hospitalizations and 43% of the deaths to meat. (2) The Food and Drug Administration (FDA), the primary federal agency tasked with regulating food, is aware of these statistics, and characterizes them as "largely preventable." (3) It is becoming clear that modern meat production methods allow pathogens to spread with ease, creating great food safety risks. (4) Startling numbers of people continue to get sick each year from food, even though regulators believe the harms are preventable, and know the source of many of the risks. This Note explores why the United States underregulates its food as compared to other nations, and suggests improvements to the domestic regulatory structure that would facilitate better regulation.

FDA's failure to improve foodborne disease rates in recent decades evidences its struggle to ensure basic food safety. The agency is, perhaps not surprisingly, even less successful at protecting against those harms that do not immediately manifest themselves, and against those emergent risks that have not been thoroughly analyzed. This Note considers public health risks associated with food production that are not at the forefront of regulation. A case study of the use of hormones and antibiotics in meat production illustrates that the division of responsibilities among agencies for monitoring farmed food has resulted in under-regulation of an industry that is vital to protecting human health. Part II introduces the primary agencies involved in regulating food, and provides some background on the use of hormones and antibiotics in farming. Part III outlines some of the scientific studies that have been conducted on these farming practices. Part IV discusses U.S. regulation of hormones and antibiotics, and Part V provides a comparison with the practices of the European Union. Part VI illustrates how the political and economic systems surrounding food regulation in the United States account for the leniency of its regulations. Part VII draws conclusions about the main problems that cause under-regulation in the United States, and explains why FDA is central to solving these problems. Finally, this Note provides three proposals to improve the food safety regime.

II. BACKGROUND

A. FOOD SAFETY RESPONSIBILITIES OF FDA, USDA, AND EPA

Multiple agencies participate in ensuring the health of meat-eating Americans by regulating meat production. Three of the agencies heavily involved are FDA, the United States Department of Agriculture (USDA), and the United States Environmental Protection Agency (EPA). Each agency's mission statement makes clear both why it is involved in food regulation and why no single agency is responsible for all aspects. The agencies' mandates often overlap, resulting in multiple agencies regulating the same product or process, making effective regulation difficult.

FDA's mission centers on public health. With respect to food, FDA must "protect[] the public health by assuring the safety, efficacy and security of ... our nation's food supply.... FDA is also responsible for advancing the public health by ... helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health." (5) Its mission also includes protecting animal health. (6) In this realm, FDA approves and monitors the safety of drugs given to animals, and is responsible for ensuring that drugs administered to farmed animals do not make their food products unsafe to consume. (7) In the context of farmed animals, then, FDA is the primary authority on the safety of drugs administered to the animals for both animal and human health.

USDA has a notably different mission: "[t]o expand economic opportunity ... to promote agriculture production sustainably that better nourishes Americans while also helping to feed others throughout the world." (8) Congress established USDA in 1862, in order "to make sure that enough food was available at all times to feed the population"; (9) its original mission was essentially to aid American farming interests. (10) Because USDA's role in food regulation is to promote agriculture, it must consider economic effects of potential farm regulations. The agency's mission statement also provides, however, that it should consider the sustainability and the health effects of the farming practices it regulates.

Finally, EPA is often involved in food regulation because its purpose is to "protect human health and the environment." (11) This Note focuses on FDA and USDA, although in many cases, the interaction of three or more agencies leads to even greater confusion and malfunction than is explored here. (12)

When multiple agencies share responsibility for regulating a single product or process, competing interests and an unclear division of authority often impede effectiveness. In spite of such institutional impediments, it is important that meat production be regulated properly, perhaps now more than ever. Since 1910, annual per capita beef consumption in the United States has consistently ranged between thirty-four and eighty pounds. (13) However, the environment in which meat is produced is very different than it was just decades ago; this new environment has proven to be an excellent breeding ground for illnesses that can infect animals and in turn harm the humans who eat them.

The long-term impact of many farming techniques remains unknown; however, current practices clearly pose serious health risks. Modem centralized food production creates the perfect environment for disease to spread by keeping enormous quantities of animals in small, confined spaces. (14) If our modern food system is not carefully regulated, pathogens will spread widely and at alarming rates. (15) Illustrating the ease at which pathogens could spread, "investigators once traced back the origin of a single lot of hamburger at one processing plant to slaughterhouses in six different states and to an almost imaginable 443 individual animals." (16) Instead of fixing the faults in the food production system, the agencies instead place the responsibility to ensure safety on those with much less control, the consumers: "[i]n the absence of better oversight of safety at the production end, federal agencies now advise us to follow safety guidelines that used to be reserved for travelers to developing countries." (17) This need not be the case, however. For example, while 45% of egg-laying chicken flocks in the United States are infected with Salmonella enteritidis, the pathogen barely exists in many other countries' flocks. (18) Thus, food safety is achievable; the United States simply makes it appear to be unachievable.

B. DEVELOPMENT OF HORMONES AND ANTIBIOTICS, THEIR USES, AND WHY THEY ARE CONCERNING

Large farms use hormones and antibiotics to make animals produce more food faster, and to prevent any illnesses that modem farming techniques may cause. Large corporations constitute a sizeable portion of meat producers. In 1998, the top four chicken-processing corporations slaughtered 49% of chickens, and the top four cattle-processing corporations slaughtered 79% of cattle. (19) These animals create huge masses of manure, which can easily transport pathogens to other animals or other sources of food. Exacerbating the problem, large quantities of animals are often transported between states or even countries in tight, poorly ventilated spaces. (20) This is an excellent environment for disease to spread, making oversight more necessary than ever.

1. Hormones

Since FDA approved Monsanto Company's application for the use of recombinant growth hormone (rBST) (21) in 1993, farmers have widely used it to increase milk production in dairy cows. (22) There is some concern that drinking milk from cows treated with rBST may cause various cancers, although studies have reached conflicting conclusions on the topic. (23)

As of 2015, Canada, Australia, New Zealand, and South Africa, among others, had also approved the use of rBST to increase meat production in cows. (24) The drug increases efficiency on now-prevalent factory farms. (25) The growth in scale of the meat and dairy industries is astounding: in 1991, 11.5% of farms had more than 100 dairy cows; in 2006, that percentage had increased to 23%. (26) By 2007, 3350 farms had over 500 dairy cows. (27) The percentage of cows receiving rBST increased at an even faster rate, from 10.1% in 1996 to 22.3% in 2002, more than doubling in less than ten years. (28) Perhaps not surprisingly, the farms with the highest rates of rBST use were those with at least 500 dairy cows. (29) By 2002, over half of these large dairy farms used rBST. (30)

One concern regarding administering hormones to dairy cows is its potential to cause increased somatic cell count. Somatic cell count is a measure of the white blood cells in raw milk, and is an indicator of both the cow's udder health and the quality of milk the cow produces. (31) Ensuring that milk quality is appropriate for consumption is clearly within FDA's regulatory purview.

Hormone use may also increase the risk of a cow developing clinical mastitis, or "inflammation of the mammary gland and udder tissue." (32) In 1996, 13.4% of dairy cows had clinical mastitis; this increased to 14.7% in 2002, and 16.5% in 2007. (33) FDA notes that the number of cows afflicted increased between 2002 and 2007, even though the number of cows that were administered rBST decreased in that time. (34) These data led FDA to conclude that the mastitis was likely not caused by rBST, and that "[a] more likely relationship might be found with the increased annual yield of milk per cow each year." (35) If FDA's hypothesis is correct, then the hormone may still be indirectly responsible for the affliction, by spurring an increase in milk production.

Although mastitis's implications for human health are contested, (36) the ailment's treatment is known to be dangerous. When a cow develops mastitis, she will likely be treated with antibiotics. (37) About 90% of cows afflicted with clinical mastitis were treated with antibiotics in 2002 and 2007. (38) The prevalence of mastitis, caused by widespread hormone use, creates a substantial amount of antibiotic administration that would otherwise be unnecessary.

2. Antibiotics

Antibiotics are administered to farmed animals through their food or water on a regular basis to cause rapid weight gain. (39) The primary concern regarding regular antibiotic use in farming is that it facilitates antibiotic resistance. Concern about antibiotic use has ballooned in recent decades. (40) Governments around the world consider antibiotic-resistant bacteria a major threat to public health. (41) The World Health Organization (WHO) defines some antibiotics as "critically important for the treatment of serious human infections." (42) Because some of the antibiotics used to treat human infections are the same as those used to treat disease in animals, (43) if antibiotics cease to treat a disease in animals, they may fail to treat the disease in humans as well.

In order to decrease antibiotic resistance, public health officials are instructing human doctors and patients to prescribe and use antibiotics carefully, and only when necessary to treat illness. Thus, feeding farm animals antibiotics daily is in conflict with current public health practices. Shockingly, about 75% of all antibiotic use in the United States is on healthy farm animals. (44) Antibiotic usage in animal feed will likely have a direct affect on both animal and human health, if it has not yet. One study by The New England Journal of Medicine found that about 80% of supermarket meat harbored antibiotic-resistant bacteria. (45) FDA studies of supermarket meat in 2011 also found many antibiotic-resistant bacteria. (46) These data, when analyzed, revealed that 53% of raw chicken had antibiotic-resistant Escherichia coli, and of the 9% of raw chicken containing Salmonella enteritidis, 74% was antibiotic-resistant. (47)

The United States Centers for Disease Control and Prevention (CDC) estimates that antibiotic resistance caused over 2 million illnesses and 23,000 deaths nationally in 2013.48 CDC pointedly wrote that the "single most important action needed to greatly slow down the development and spread of antibiotic-resistant infections is to change the way antibiotics are used. …

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