Notice & Comment

FDA’s International Agreements: Typologies and Purposes

In my last post, I situated FDA’s international agreements in the literature on “global administrative law” and suggested that the field’s leaders take too narrow a view of what regulators do in the process of “making” global administrative law. Their regulatory mission is often much broader than the product or sector so-described. FDA’s international agreements in the food regulatory space provide a fruitful area to explore what regulators are really doing.

Confidentiality Agreements

FDA has over 120 international agreements in place with about 30 countries and multilateral partners. Of these, nearly half are confidentiality commitments which allow FDA to share information, protect information disclosed by regulatory partners, and take measures to ensure that any disclosure of information provided by a regulatory partner is done so according to law and with minimal disturbance to the regulatory partner’s mission. FDA and the Controlled Substances and Tobacco Directorate of the Healthy Environments and Consumer Safety Branch of Health Canada, for example, have entered into a detailed agreement governing the sharing of information related to tobacco control. While confidentiality commitments between the FDA and regulatory partners begin with a standard one page template, there is significant variation between the terms that FDA is able to negotiate and memorialize.

Statements of Cooperation or Intent

If confidentiality commitments represent the shallowest form of international regulatory cooperation FDA undertakes (which may explain the large number FDA has in place), statements of cooperation represent a next step toward more extensive cooperative activities. Statements of cooperation or intent outline general contours of product-specific regulatory possibilities with partners with robust cooperative histories or foreshadow greater cooperation with regulatory partners with whom cooperative activities are not well-established. In 2005, for example, FDA entered a Statement of Intent with Mexican agencies SENASICA and COFEPRIS to explore a workplan that would “achieve mutual confidence” in the other’s produce safety systems for fresh and minimally processed products. In 2012, FDA entered into a Statement of Cooperation with the Brazilian health regulatory authority ANVISA regarding “cooperation to enhance activities of mutual interest.” The statement reads very much like two parties who have infrequently dealt with one another and, even when so, have not endeavored to obtain a full understanding of the other’s regulatory approaches. The Statement of Cooperation outlines five categories of information exchange, collaboration, mutual investigation, and shared research interests that might form the basis of more detailed regulatory cooperation in the future.

Exchanges of Letters

Where FDA is unable to reach mutually agreed terms, bilateral terms are generally expressed as “positions” with tacit understanding as to differences held by regulatory partners, or where special circumstances otherwise obtain, FDA enters into “exchanges of letters” which articulate the respective positions of the parties with the aim of reducing, if not eliminating, barriers to regulatory cooperation. For example, pufferfish contain a potentially lethal neurotoxin, tetrodotoxin, in their internal organs and even skin but are regarded as a delicacy in China, Korea, and Japan where specially trained chefs know which parts of the fish to safely prepare and in what quantity. Pufferfish have long been on FDA’s list of automatic detention products precisely because there is no way to approve an incoming “lot” of the fish; any one fish may contain a lethal amount of tetrodotoxin. In 1988, the FDA and the Japanese Ministry of Health and Welfare entered into an exchange of letters under which exporters following a specific protocol would address FDA’s concerns and thus encounter fewer problems at the border. In 1995, FDA entered into an exchange of letters with the New Zealand Ministry of Agriculture and Fisheries which committed FDA to a 99% “may proceed rate” border approval upon certain certifications from the New Zealand agency, although the final letter in the exchange made clear that each party retained certain “understandings” with respect to the approval program.

In my next post, I will analyze FDA’s memoranda of understanding, systems recognition agreement, and agreements that operate within a broader bilateral relationship, and formal agreements or quasi-treaties.

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