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China and the FDA’s Proposed Rule on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: A Barrier to International Trade?

China and the FDA’s Proposed Rule on Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: A Barrier to International Trade?

Rachel Gaudio

The Food and Drug Administration (FDA) has recently introduced numerous regulations in accordance with the Food Safety Modernization Act (FSMA) enacted in 2011. The FDA’s most recent proposed regulation aims to regulate Foreign Supplier Verification Programs (FSVPs), specifically those that import foodstuffs into the United States for human and animal consumption.[1] In order to participate in import programs with the United States, foreign suppliers will have to comply with U.S. processes and risk-based preventive controls in order to better protect the public health. This is meant to work in conjunction with the Federal Food, Drug, and Cosmetic Act (FD&C Act).[2]

The need for such a rule becomes increasingly apparent due to public interest in consumer safety and food safety.[3] Headlines are made during food crises, regardless of whether the contaminated food affects humans or animals.[4] It is important to determine how major players in the food trade industry will be affected by the proposed rule. Complying with domestic food laws may affect the ability to conform with US standards. China is an important player in this chain. As China increases trade with the US, it is important to remember that China itself is advancing numerous environmental laws of its own. The United States and China have entered into an agreement that will allow both countries to advance food safety regulations, encourage trade, and promote consumer confidence in traded foodstuffs.[5] While these laws are meant to reduce public health accidents, China has a difficult time enforcing their laws due to the rate at which they are produced and the number of people they have available to ensure compliance. This note is meant to analyze possible challenges China faces under the new FDA proposed rules and how this will affect trade with the US.

This note will address the background of the prevalent laws and also provide a general background of Chinese Environmental Law. It will then continue on to analyze potential challenges facing Chinese food suppliers and how the rules may apply in an ongoing Chinese food crisis. Further, it is important to note that this proposed rule is open for public comment until November 26, 2013. Depending on the FDA’s response rate to these comments, this note will consider the responses and any amendments to the rule set forth by the FDA. Will this proposed rule become a barrier to international food trade? Will Chinese suppliers experience difficulty selling their goods to American markets? How will this rule apply in the event of a food crisis? What are the lasting implications of the proposed rule? Stay tuned for an analysis of this current issue.

Questions and inquiries regarding this Note may be sent to the author at






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