FSMA Conference Part 4: Benefits, Challenges, and Gaps in FSMA’s Approach

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Jeffrey Skopek

Lewis Grossman, Washington College of Law, American University – New Governance, New Challenges

Professor Grossman opened the panel by locating FSMA in the context of the “new governance” movement that has arisen in response to the limits of command and control regulation.   Some of the key features of new governance include stakeholder participation, public/private partnerships, bottom up rulemaking, consensus orientation, context-specificity, and dynamic and adaptive learning.    After discussing the benefits of new governance, he turned to a discussion of some of its limits, focusing on general ways in which it can increase the costs of regulation.   These include the costs of overseeing a regime that relies on self-regulation by parties for whom it is in their interest, as well as the costs of regulating the other parties for whom self-regulation is not in their interests.  The final part of the talk discussed some of the ways in which FSMA might increase the resources required by the FDA.  For example, because FDA inspectors are generalists who deal with both food and drugs  (there are not “food inspectors”), FSMA training will be more costly.   Further, while FSMA calls for the FDA to leverage the safety resources of state and local inspectors, this coordination must be funded, which can be expensive (e.g., the necessary information infrastructure is costly).   Finally, because the foreign third party certification system is decentralized and relies on private auditing services, it creates new possibilities for moral hazard and fraud that will require greater FDA oversight.

Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan – FDA and Uncertain Health Risks: Regulating Veterinary Drugs in Feeding Food Animals

Professor Ni started his talk with an overview of growing concerns about how food animals are processed and produced, citing the growing number of companies that are voluntarily phasing out foods that contains antibiotics and hormones that are allowed by the FDA.  He then turned to a comparative discussion of how the US and EU have regulated hormones and antibiotics in food.   He noted that while the US has a fairly permissive approach, the EU has taken a precautionary approach.   He then discussed the pros and cons of the FDA’s approach, comparing the viewpoints of consumers, farmers, and drug makers.   The final part of this talk focused on risk analysis.   Professor Ni provided an overview of the three phases of risk analysis: risk assessment, risk management, and risk communication.  He argued that these three phases are needed to ensure that the governance of risk is science-based, responsive to competing policy concerns, and transparent.    In providing an overview of the FDA’s use of this process in other contexts (as well as the global trend), he highlighted some limits of the FDA’s approach.   He argued that risk analysis is a core principle of FSMA, and that while the FDA has started to build this type of governance regime, it needs to bring the science-finding and policy-making closer to the general public.

Stephanie Tai, University of Wisconsin School of Law – Whole Foods: The FSMA and the Challenges of Defragmenting Food Safety Regulation

Professor Tai opened with a discussion of why should we be concerned about fragmentation in policy making in this and other areas, suggesting that the problems include policy gaps, duplicative efforts, and inconsistencies.   She then turned to a discussion of the cause of fragmentation and the various actors who are involved in setting food policy, which include not only a host of federal actors (e.g., FDA, USDA, CDC, EPA), but also state and local regulators, the food industry, and consumers.  She suggested that while FSMA does not focus on enhancing coordination, it has many coordination-improving elements.    For example, it expands the FDA’s oversight authority, shifts the focus to prevention, and requires interagency collaboration in areas such as inspections, seafood safety, and food imports.   She also emphasized that it is hard to know what types of collaboration are happening behind closed doors and provided a survey of varying degrees of coordination that have been mentioned in proposed rules.   The final part of the talk focused on coordination challenges.  She highlighted examples of informational challenges (e.g., key information is still not shared by the computer systems of FDA, FSIS, and US Customs), policymaking challenges (e.g., the focus of performance measures is on integration into the budgeting process, not the policymaking process), statutory challenges (e.g., the lack of changes to USDA’s authority and mission), and structural challenges (e.g., the FSWG is not permanent and factors of political economy may provide reasons for retaining fragmentation).  She closed with a quick outline of proposals for statutory changes and non-statutory changes that could increase coordination.

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