Squashing the superbugs: a proposed multifaceted approach to combatting antibiotic-resistant bacteria.

• Author: Orrico, Lauren

1. INTRODUCTION II. BACKGROUND A. Factory Farming B. The Current Health Threat: Antibiotic Resistance C. Costs of Factory Farms 1. Economic Costs 2. Social Costs D. Overview of Food and Drug Regulations 1. The Food, Drug, and Cosmetic Act 2. The Food and Drug Administration III. ARGUMENT A. Current Laws B. Shortcomings of Current Food Policy 1. Limits of FDA action 2. National Resources Defense Council v. Food and Drug Administration C. Proposed Changes 1. Make Certain Standards Legally Binding through legislation 2. Develop Clear FDA Definitions and Guidelines 3. The Role of the Courts IV. CONCLUSION I. INTRODUCTION

   In 1977, disco flairs were all the rage, quarterback Tom Brady was only just born, and investors had the option to buy stock in a new company called Apple, which was incorporated in January of that year. (1) Economic and spending considerations were also at play in the 1970's as President Jimmy Carter attempted to fight unemployment by allowing the federal deficit to swell and establishing job programs. (2) Finally, 1977 saw the Food and Drug Administration (FDA) issue notices announcing its intent to withdraw approval of the use of certain growth-promoting antibiotics in animals raised for food (commonly referred to as "food animals"). (3) The FDA found that broad use of these antibiotics led to the development of antibiotic-resistant bacteria. (4) These bacteria were deemed detrimental to human health because they caused antibiotic-resistant infections, which were difficult to treat. (5) Thirty-five years later, few people would suggest giving those bell-bottoms another spin or debate the success of Apple, but the threat of antibiotic resistance is growing ever larger and costing Americans billions of dollars each year. (6)

   Although government policies have evolved in the last thirty-five years, Americans still understand the importance of balancing costs and benefits, and of making sacrifices now to ensure a safe world for future generations. Antibiotic-resistant bacteria threaten the health of current and future generations if their effects are not curbed soon. (7) According to the Infectious Diseases Society of America (IDSA), just one antibiotic-resistant organism, Methicillin Resistant Staphylococcus Aureus (MRSA), (8) kills more Americans every year than emphysema, HIV/AIDS, Parkinson's disease, and homicide combined. (9) The economic cost of antibiotic-resistant infections to the United States health care system is twenty-one billion to thirty-four billion dollars each year--along with an additional eight million hospital days for patients. (10) These economic costs, along with the social costs of environmental degradation, animal cruelty, and adverse health effects, make cost-effective policy initiatives crucial for preserving the health and well-being of our society. (11)

   The spread of antibiotic-resistant infections is finally being widely recognized by medical professionals as a serious threat that can be slowed through proper policy. (12) Resistant bacteria multiply when antibiotics are overused. (13) As around half of all antibiotics used in the United States are given to animals for various reasons, overuse in food animals is a major cause of this problem. (14) Numerous studies have linked the wide-spread use of antibiotics in animal feed to the development of antibiotic resistance in humans. (15) Antibiotic resistance has led to massive food recalls and a higher prevalence of drug-resistant infections, allergies, and autoimmune diseases in children. (16) However, current legislation fails to address the problem, preferring instead to defer responsibility to the hesitant FDA (17)

   The FDA, although recognizing the health concern as far back as 1977, has refused to ban the use of antibiotics for disease prevention and growth promotion in food animals. (18) However, a recent U.S. District Court ruling brought subtherapeutic use back into the public spotlight when it ordered the FDA to follow through on proceedings initiated in 1977 to ban the subtherapeutic use of certain antibiotics in livestock. (19) The FDA has resisted, however, pointed out the detriment that an outright ban would have on our modern factory farming system and preferring to allow large farms to solve the problem them. (20) The FDA appealed the District Court's ruling, and the Second Circuit reversed the decision in July 2014. (21) While this reversal may mean the FDA is not legally obligated to continue withdrawal proceedings, the case has brought an important health threat to the public's attention and has the potential to serve as a foundation for a reform movement.

   New legislation is needed to reduce both the economic and social costs of subtherapeutic antibiotic use--taking into consideration the needs of farmers and the cost to the public of more expensive food. Even if the ruling had not been reversed, the ruling had several limitations. The ruling did not specify how the FDA must tackle the problem and only applied to a limited class of antibiotics. (22) Accordingly, the economic and social costs of antibiotic resistance must be combated through congressionally mandated standards and requirements, mandatory FDA withdrawal of subtherapeutic antibiotic use in food animals, and procedural enforcement through the courts. These policies should be phased in and should consider costs to farmers and to the public.

   Section II of this Note will provide background on the practices of the United States farming system, which fosters the creation of antibiotic-resistant bacteria. This section will also provide background on the detrimental effects that antibiotic resistance has on human health and will briefly describe the legal history of food and drug regulations. After establishing an informational foundation, Part III will elaborate on current laws and describe the legal authority of key players, before pointing out the shortcomings in current animal feed policy and recommending the development of further regulation in this area. Additionally, Part III will propose new legislation to address social and economic costs, while also addressing the needs of farmers and meat consumers. This Note proposes a three-tiered approach for tackling the problem of antibiotic resistance based on congressional legislation, mandatory FDA standards, and proper court enforcement. Finally, this Note will conclude with a restatement of the essential issues and the way in which the proposed legislation will alleviate those problems.

2. BACKGROUND

   Subtherapeutic antibiotic use (23) is necessary due to the existence of large factory farms, which keep profits high and meat prices low. (24) Factory farms pack a multitude of animals into small spaces where disease can spread quickly. (25) These close conditions make preventative disease treatment the only practical way to prevent mass epidemics. (26) Unfortunately, this practice has the adverse effect of creating antibiotic super bugs, which spread to other animals, the earth, and humans. (27) The federal government has attempted to ensure meat safety through legislation, the creation of executive agencies, and enforcement in the courts. (28) These efforts have fallen short.

   1. Factory Farming

      The vast majority of food animals are raised on factory farms. (29) Between 2002 and 2007, many small to medium sized farms gave way to massive factory farms, (30) largely due to a lack of antitrust and environmental regulations, as well as indirect subsidies to the farming industry. (31) Factory farms enclose high concentrations of animals in small areas and unsanitary conditions in order to keep food production costs low and profits high. (32) These cramped conditions are ripe for bacterial epidemics because disease can easily spread from animal to animal. (33) For these reasons, the industry faces a fundamental problem: preventing the spread of disease among animals kept in close quarters.

      During the 1950s, the food animal industry began experimenting with "nutritional factors" aimed at increasing animal growth and soon discovered that low doses of antibiotics increased growth. (34) As the full implications of broad antibiotic use remained unknown in the 1950s, (35) antibiotics were classified as "nutritional" and premixed into food without a prescription at low, subtherapeutic levels. (36) Subtherapeutic doses are generally about ten to one hundred times lower than therapeutic doses, are prescribed over a longer period of time, and are not directed against a particular microorganism. (37) Instead, subtherapeutic doses broadly protect against infection and promote growth so that animals can be slaughtered faster. (38)

      Today, in addition to antibiotics, premixed animal feed may contain hormones, animal waste products, and parts of animals not fit for human consumption. (39) The amount of antibiotics present in animal feed has steadily increased to almost therapeutic levels, as the food animals build up resistance to the lower doses. (40) Antibiotic resistance has been scientifically linked to across-the-board usage of subtherapeutic levels of antibiotics in food animals. (41)

   2. The Current Health Threat: Antibiotic Resistance

      Subtherapeutic antibiotic use in food animals greatly increases the presence of antibiotic-resistant bacteria in those animals. Antibiotics are drugs used to treat infections caused by bacteria. (42) Although antibiotics are a great asset for treating illnesses, overuse leads to a phenomenon known as antibiotic resistance. (43) Antibiotic resistance can develop in humans or animals; however, since the vast majority of antibiotics are given to food animals, their bodies are the main breeding ground for antibiotic-resistant bacteria. (44) Animals' bodies contain both bacteria that can be treated by antibiotics and bacteria that have, through random chance, genetically mutated so that antibiotics are ineffective against them. (45) The latter type is known as...