Outsource Power, Import Safety? Challenges and Opportunities of the U.S.-China Food Safety Regulatory Cooperation.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY
Food and drug law journal Pub Date : 2017-01-01
Ching-Fu Lin
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Abstract

The United States has a high stake in China’s serious food safety problem, as food products of Chinese origin have dominated the U.S. food market in numerous areas and continue to grow. The conclusion of the U.S.-China Food Safety Agreement (“the Agreement”) has allowed FDA to strengthen regulatory cooperation with its Chinese counterpart in various aspects. The Agreement also paves the way for the implementation of the new regulatory tools incorporated in FSMA, especially in the cross-border context. However, both the Agreement and FSMA have certain crucial limitations that may create future hurdles to effective implementation in the U.S.-China cooperation. This paper therefore endeavors to first examine China’s governance challenges over food safety, with a focus on the 2009 Food Safety Law, the 2015 Amendment, and the fundamental problem of “thin” rule of law. This paper moves to analyze the U.S.-China Food Safety Agreement, reviewing the agreement’s strengths and weaknesses. It further assesses FSMA’s innovative institutional design to regulate imported food products and its limitations. However, both the U.S.-China Food Safety Agreement and FSMA arguably create a regulatory dilemma for FDA when addressing imported food safety, due to structural mismatch between the broad scope of power granted to FDA and the long chain of power outsourcing to governments or private companies as primary “regulators.” Neither the Agreement nor FSMA give FDA adequate capacity to closely oversee such “agents” along the chain of power outsourcing. Framing the U.S.-China food safety cooperation as a multilayer structure that “outsources power” to “import safety,” this paper concludes by stressing the need for a robust accountability and effective mechanism for U.S.-China food safety cooperation.

外包电力,进口安全?中美食品安全监管合作的挑战与机遇。
中国严重的食品安全问题与美国利害攸关,因为中国食品在许多领域主导了美国食品市场,并在继续增长。《美中食品安全协定》(以下简称《协定》)的签订使食品药品监督管理局得以加强与中国食品药品监督管理局在各方面的监管合作。该协议还为实施纳入FSMA的新监管工具铺平了道路,特别是在跨境背景下。然而,《协定》和《食品安全协定》都有某些关键的限制,可能会对美中合作的有效实施造成未来的障碍。因此,本文试图首先审视中国在食品安全方面面临的治理挑战,重点关注2009年的《食品安全法》、2015年的《食品安全法》修正案,以及“单薄”法治的根本问题。本文分析了中美食品安全协议,回顾了该协议的优点和缺点。它进一步评估了FSMA监管进口食品的创新制度设计及其局限性。然而,《美中食品安全协议》和《食品安全sma》在解决进口食品安全问题时都可能给FDA造成监管困境,因为FDA被授予的广泛权力范围与作为主要“监管者”的政府或私营公司的权力外包长链之间存在结构性不匹配。该协议和FSMA都没有赋予FDA足够的能力来密切监督电力外包链上的这些“代理商”。本报告将美中食品安全合作描述为一个将权力“外包”给“进口安全”的多层结构,最后强调需要建立一个强有力的问责制和有效的美中食品安全合作机制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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