Notice & Comment

FDA’s Memoranda of Understanding, Quasi-Treaties, and their Role in the Future of Global Administrative Law

In my last post, I detailed the kinds of agreements FDA uses with regulatory partners as part of a three-post series that examines FDA through the lens on the growing literature on “global administrative law.” This final post analyzes FDA’s “steepest” commitments with regulatory partners and argues that in the process of contributing to global administrative law, FDA also plays explicitly political and diplomatic roles that are poorly accommodated by existing accounts of what global administrative law is and what it does.

Memoranda of Understanding

The FDA uses Memoranda of Understanding which do not have a standard form like confidentiality commitments and take a variety of forms that suit specific regulatory or product factors. The purpose of these agreements is to memorialize intended cooperation with foreign partners with the goal of improved safety and quality of regulated goods and components imported into the U.S. The 2012 MOU between the FDA and the Mexican National Agro-Alimentary Health, Safety and Quality Service Concerning the Entry of Mexican Cantaloupe into the U.S is a good example of a product specific agreement. Cantaloupe and other melons present special food safety risks. Unlike other fruits, cantaloupe are not acidic and readily support the growth of pathogens once they are sliced open. Foodborne illness outbreaks from cantaloupe have been traced back to wash water, shipping ice and even contact with contaminated meat. For these reasons, FDA categorizes cut melon as a potentially hazardous food and it therefore receives substantial regulatory attention. The MOU facilitates the implementation of a system that increases the likelihood that cantaloupe from Mexico that will be imported into the U.S. complies with U.S. law, and facilitates a risk-based system to help ensure that the cantaloupe is safe for consumption. Other examples of product specific agreements include several MOUs regulating dry milk products, shellfish safety, milk proteins, and fish. MOU relationships can be much broader and context specific.

Systems Recognition

Systems Recognition arrangements differ from MOUs in that they represent broader, comprehensive assessments of regulatory objectives and capability and offer mutual recognition based on comparable levels of protection of public health. The concept of Systems Recognition is a relatively new one for FDA, although it was based on previous assessment templates.

In 2012, after the FDA’s extensive review of New Zealand’s food safety control system, FDA and New Zealand’s Ministry for Primary Industries (MPI) entered into a Food Safety Systems Recognition Arrangement that acknowledged that the FDA and MPI have comparable food safety regulatory systems that lead to a similar level of food safety assurance. Reaching that conclusion and codifying it required lengthy mutual assessment of the operation of the food control systems in effect in each country as well as more in-depth reviews of the regulatory systems in place for commodities of higher regulatory interest like dairy products. The Systems Recognition agreement indicates an intention for the two agencies to work cooperatively when food shipped between them has safety issues, and to take any appropriate risk management interventions needed to ensure food safety while minimizing trade disruptions.

Agreements within Broader Bilateral Cooperative Partnerships

On February 4, 2011, Prime Minister Stephen Harper and President Barack Obama announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) to increase regulatory transparency and coordination between the two countries. In general, Canadian and U.S. delegates to the RCC undertake efforts to better align the regulatory environment between Canada and the United States through enhanced technical collaboration, mutual recognition of standards and joint work sharing. The initial Joint Action Plan establishes collaboration between FDA and Canadian Food Inspection Agency (CFIA), Health Canada to promote regulatory alignment and mutual reliance in areas such as product review and the inspection of facilities. CFIA and FDA will assess each other’s food safety systems and establish a food safety systems recognition arrangement based on the results. The exchange of food safety information will be increased to help both countries make informed risk-based regulatory decisions. For example, CFIA and FDA have compared Canadian and U.S. accreditation criteria for food testing laboratories and analyzed the similarities between them. Moving forward, Canadian and U.S. food safety regulators will develop criteria, processes, and tools to facilitate mutual reliance on food testing results under the direction of an existing Canada-FDA Joint Committee on Food Safety. As the FDA and the CFIA implement their modernized food safety rules and regulations, they will work together to ensure that their systems deliver comparable public health outcomes and reduce unnecessary duplication wherever possible. In short, the FDA-CFIA initiative within RCC plays an analogous role to systems recognition which is a standalone arrangement with New Zealand.

Agreements or Quasi-Treaties

FDA may also enter into agreements that, while not technically “treaties”, wear the insignia of binding agreements. The 2007 Agreement between FDA (and, more broadly, the US Department of Health and Human Services) and China’s General Administration of Quality Supervision, Inspection and Quarantine on the Safety of Food and Feed provides a relatively lengthy provision defining terms, mandating specific action from each party, including production of “copies of, and other relevant information concerning, their respective laws and regulations relating to food and feed safety”, and specifying points of contact for covered cooperative activities and undertakings. Unlike most FDA agreements, the Agreement with AQSIQ includes extensive annexes, expiration and termination provisions, and specific commitments within each aspect of the agreement.

As demonstrated by these examples, FDA cooperation with foreign partners can take many forms, challenging the unitary functions now commonly attributed to regulators participating in transgovernmental networks. FDA’s agreements may be at once inconsistent with the letter and expectations of international trade law yet also reducing the likelihood that regulatory measures might be challenged. Similarly, the “softness” or “hardness” of the agreement may aim not at core regulatory objectives but rather in establishing a specific kind of regulatory relationship or encouraging the dissemination of official or at least more reliable information from regulatory partners. As globalizing forces increasingly intertwine consumer protection, trade, and financial regulators, the complexity of international networks and related international institutions will need to develop methodologies to assess which “hat” any given participant is wearing.

Print Friendly, PDF & Email