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Introduction

The antibiotic penicillin was first discovered in 1928,1 and it represented a significant medical breakthrough. These drugs have proven very effective in containing and eliminating germs, such as E.

coli. However, their rampant use has led to the occurrence of drug resistance, which in turn creates alleged superbugs. The problem first raised attention in the 1960s. The World Health Organization (WHO) has studied the issue for decades using data from 114 countries. In April 2014, the WHO published the first official global report on antibiotic resistance, highlighting that it has become a common and serious public health crisis.2 A WHO official emphasized, “[u]nless we take significant actions to improve efforts to prevent infections and also change how we pro­duce, prescribe and use antibiotics, the world will lose more and more of these global health goods and the implications will be devastating.”3

The European Union (EU) has swiftly responded to the health risks caused by antibiotic resistance. In the 1990s, a strong scientific finding on the link between the use of antibiotics in food animals and antibiotic resistance in

* Preliminary research on this topic was partially published in Chinese in Taiwan Law Review, No. 246, pp. 172—185 (2015). An earlier version was presented at thelnternational Conference on Food Law and Policy: Food Safety and Technology Governance, Taipei, Taiwan, May 10—11, 2019. This chap­ter has been modified and updated in accordance with new developments. The study was supported by a research grant from the Ministry of Science and Technology (MOST), Taiwan, the Republic of China (108-2410-H-009-028-MY3).

1 http://en.wikipedia.org/wiki/Antibiotics.

2 WHO, “Antimicrobial Resistance: Global Report on Surveillance 2014,” available at http://apps. who.int/iris/bitstream/10665/112642/1/9789241564748_eng.pdf (last accessed Jan.

30, 2020). The recent survey on the issue see “Global Antimicrobial Resistance Surveillance System (GLASS) Report: Early Implementation 2016—2017”, available at https://apps.who.int/iris/bitstream/han dle/10665/259744/9789241513449-eng.pdf?sequence=1 (last accessed Feb. 3, 2020).

3 The remarks of Dr. Keiji Fukuda, “WHO's Assistant Director-General for Health Security”, at www. who.int/mediacentre/news/releases/2014/amr-report/en/#.U3El598DvKc.facebook (last accessed Feb. 15, 2020).

DOI: 10.4324/9781003271918-3 humans had yet to be confirmed. Based on a precautionary consideration, the EU began to ban the use of antibiotics for growth promotion. The European Court of Justice had confirmed the legality of applying the precautionary principle as a basis in outlawing antibiotics for such an application.[19] As more data emerges, several competent European health authorities have jointly found that antimicrobial resistance can be transmitted to humans from animals and food.[20]

In the United States (U.S.), the production and use of antibiotics used to be relatively popular in treating illness and promoting the growth of food ani­mals. It has been more than 50 years since the U.S. began to approve the mar­keting of antibiotics.[21] Past regulatory regimes[22] were also friendly toward the pharmaceutical industry. Consequently, more than 80% of antibiotics are used in livestock.[23] Most food animals consumed by human beings contain residual antibiotics. Drug resistance in humans caused by the overuse of antibiotics in promoting animal growth alerted the U.S. Food and Drug Administration (FDA). In the 1970s, the FDA initiated a withdrawal process for certain ani­mal drugs authorized by the Food, Drug, and Cosmetic Act (FDCA),[24] but it suspended the procedure shortly thereafter. After 30 years, the FDA decided to change its course of action. Instead of reinstating the original withdrawal process, the FDA considered a voluntary phasing out of the use of antibiotics by the pharmaceutical industry, which it contended would be more effective and less costly.

Thus, the FDA issued “Guidance for Industry” documents to implement the voluntary policy.[25] Yet the decision to terminate the withdrawal process was challenged by the National Resources Defense Council (NRDC), which argued the decision violated the FDCA. The federal court eventually sided with the FDA’s decision.[26]

Since the adoption of the voluntary policy, most drug manufacturers have been willing to follow the FDA’s guidance. According to the FDA’s survey,

Phasing Out Antibiotics in Food Animals 15 the sale of antibiotics for food animals has dropped significantly since 2013.[27] The effectiveness of the policy seems quite clear. However, critics remain con­cerned about whether public health crises can be thoroughly solved, partly because the guidance documents have no binding force. Because the antibiotic restriction only applies to growth promotion and disease, preventive uses are still permitted, and it was alarming that the new policy may create a loophole with no guarantee for decreasing the use of antibiotics by farmers.[28]

In addition to briefly analyzing the judicial reviews of the courts that sided with the FDA’s position, this chapter specifically aims to reveal the regulatory approaches underlying the U.S. FDA’s policy on combating antibiotic resist­ance. The chapter will discuss how precautionary principles and cost-benefit analysis (CBA) affect the policy and disclose their implications, regardless the lack of an explicit invocation of the approaches by the FDA.

II.

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Source: Ni Kuei-Jung, Lin Ching-Fu (eds.). Food Safety and Technology Governance. Routledge,2022. — 252 p.. 2022

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