[Ed. Note: On Friday, February 21, 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 is the final installment in a series of blog posts from the event; video will follow shortly.]
By Kuei-Jung Ni
Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine – FDA’s New Import Toolkit: FSMA and Beyond
Mayl brought her first-hand experience to the conference and updated progress concerning FDA’s implementation of the FSMA mandate on food importation. She first mentioned the increasing complexity of regulating importation due to the globalization of food production and trade. Therefore, the old school method of ensuring the safety of imported food by doing border checks needs to be changed. In response to the challenges, she pointed out that FSMA shifts the paradigm by creating a multilayered safety net. FSMA Sections 301 to 309 articulate duties for relevant stakeholders that comprise manufacturer, importers, third parties, foreign regulatory bodies and FDA itself as well.
With respect to recent progress of FDA rule-making activities under FSMA, Mayl introduced two draft regulations both issued in July 2013: “Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals” and “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications”. Under the FSVP regulations, importers would be required to perform certain risk-based activities to verify that food imported into the U.S. has been produced in a manner that provides the same level of public health protection as that required for domestic food producers. One of the FSMA mandates directs FDA to establish a program for the Accreditation of Third-Party Auditors for foreign food facilities. Under the regulation, FDA would recognize accreditation bodies based on certain criteria such as competency and impartiality. Then, the bodies would in turn accredit third-party auditors to, among other things, conduct food safety audits and issue certifications for foreign facilities and food under specified programs.
Finally, Mayl briefed the efforts of FDA to build up and enhance international cooperation on food safety with both international organizations, such as the Codex responsible for setting international standards, and U.S. trading partners with which harmonized and mutual recognition arrangements could be developed.
Ching-Fu Lin, Petrie-Flom Center Student Fellow, Harvard Law School – The Role of Private Ordering in the FSMA
Lin first underscored three food safety regulatory approaches that cover product-based, process-based and management-based aspects. Those approaches, he emphasized, are not mutually exclusive and can be implemented by both public and private actors. His presentation mainly focused on the pros and cons of the management-approach that, inter alia, allows private third parties to engage in regulatory tasks. In line with other tools to apply the management approach in enhancing domestic safe food production, FSMA also embraces the idea in terms of using private third parties to audit foreign suppliers. Lin predicted that foreign producers may welcome the method mainly because they find it more efficient to locate and implement the optimal regulatory designs in relation to cross-border control. Regardless the advantage of this private ordering, Lin also revealed several challenges and risks posed by the mechanism. The draft regulation on “Accreditation of Third-Party Auditors” mentioned above involves a multi-layer delegation structure. By delegating certain authority, FDA may only know obvious and serious errors, which may lead to the dilution of accountability and effectiveness. Further, although the regulation has sensed the problem of “conflicts of interest” (COI), the current device on the protection against COI seems limited to “financial” aspects. The COI defect may compromise regulatory impartiality especially when some foreign governments face potentially conflicting “dual mandates”: auditing against U.S. standards on one hand and promoting national exports on the other. The information asymmetry between third party auditors and regulator (FDA) also needs to be fixed.
Marsha Echols, Howard University School of Law – Mandatory and Voluntary Programs for Importers,
Professor Echols’s main theme is mainly concerned with the consistency of the FSMA arrangements with U.S. obligations under international trade rules. First, she introduced governing WTO rules for applying national health related measures. The 1994 General Agreement on Trade and Tariff (GATT) literally recognizes the prerogative of WTO members to protect their public health and to decide an appropriate level of protection. But, the right shall be subject to the scrutiny of a necessity standard. More specifically, it is the SPS agreement that regulates, inter alia, food safety measures adopted by WTO members. The SPS agreement requires that national measures be of science-based and risk-based character. Alternatively, members can take a precautionary measure that may departure from such a mandate as health risks involve in scientific uncertainty.
Echols then proceeded to reveal which programs embodied in Title III of FSMA are likely to create non-tariff barrier problems. With respect to the arrangement on the accreditation of third party auditors & certification bodies, many WTO members, including China, Brazil, Belize, Korea, etc., at the recent SPS meeting taking place in October 2013, raised a specific trade concern regarding whether the “outsourced” audits and certifications comply with the SPS agreement. They were concerned with if this outsourcing government responsibility would constitute a private standard.
On FSVP, Echols considered that FSMA gives FDA a great level of discretion to decide whether foreign suppliers are acting in a manner compatible with U.S. food producing standards. The discretion should be cautiously applied to avoid the inconsistency with,inter alia, the Most-Favored-Nation (MFN) principle and the risk assessment requirement of the SPS agreement.