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AbstractThe Food Safety Modernization Act (FSMA) substantially expands the authority of the U.S. Food and Drug Administration to regulate fresh produce marketed in the United States. This article uses an equilibrium‐displacement framework incorporating stochastic food‐borne illness outbreaks to simulate long‐run market effects of FSMA using the North American fresh‐tomato industry as a case study. We demonstrate how, under FSMA, certain categories of suppliers will gain advantage over others. Growers and suppliers within the United States, and their buyers, are likely to gain relative to foreign producers and importers because FSMA imposes specific requirements for importers. Among fully regulated growers, large growers will benefit relative to small growers. Many producers have already adopted food‐safety standards that closely resemble the FSMA rules, and the cost of implementing the FSMA requirements for these producers will be much lower than for other producers.

L'autorité de surveillance des marchés financiers belge (la 'FSMA') a récemment multiplié les initiatives pour la protection des 'consommateurs financiers'. Elle a contribué à l'élaboration des règles légales nouvelles en cette matière, et a également émis des règlements, avertissements, circulaires et autres communications dans ce cadre. Une question mérite cependant d'être posée: cet activisme va-t-il à l'encontre de la sécurité juridique, de la compétitivité du secteur financier belge, et, dans une certaine mesure, des 'consommateurs financiers' eux-mêmes ? Nous tenterons d'y répondre en examinant les évolutions les plus récentes dans ce domaine au niveau (1) des obligations d'information précontractuelle et publicitaire, ainsi que des règles de responsabilité, contrôle et sanctions qui y sont liées, (2) de la 'gouvernance-produit' et (3) des 'pouvoirs d'intervention-produit'. Ces développements ont été introduits en droit belge par la réforme Twin Peaks II, le Livre VI du nouveau code de droit économique, l'arrêté royal transversal imposant un document d'information standardisé en cas de commercialisation aux investisseurs de détail, le règlement de la FSMA imposant un label de risque sur certains produits financiers et le règlement de la FSMA interdisant la commercialisation de produits financiers 'non-conventionnels' aux clients de détail. Nous conclurons par une prise de position critique sur les deux points d'attention majeurs du régulateur belge - les obligations d'information et 'l'intervention-produit'. Nous expliquerons qu'à notre avis une meilleure approche réglementaire serait de se concentrer sur la réglementation des intermédiaires financiers et la gouvernance-produit. Nous ne pouvons soutenir les initiatives de la FSMA que si elles vont dans ce sens. ; The Belgian financial supervisory authority (the Financial Services and Markets Authority or 'FSMA') pro-activity in recent months is striking. It drafted many rules and issued many regulations, warnings, circulars or other communications to increase the protection of clients who buy financial products on Belgian financial markets. But does the FSMA go too far too fast to the detriment of legal certainty, the competitiveness of the Belgian financial sector and, to some extent, financial clients themselves? This article tries to answer that question by examining some of the most recent developments in client protection on Belgian financial markets with respect to (1) provisions relating to pre-contractual and marketing information obligations, and related liability, supervision and sanction regimes, (2) product governance arrangements and (3) 'product intervention powers'. They were introduced in Belgian law by the 'Twin Peaks II package', Book VI of the new Code of economic law, the transversal marketing Royal decree, the FSMA label regulation, and the FSMA prohibition on the distribution of several non-mainstream financial products to retail clients. In the conclusions to this article, we give a critical assessment of the focus of the Belgian legislator on disclosure and product intervention. We explain that we favor point-of-sale regulation and product governance arrangements as regulatory approach to protect financial clients. Only to that extent do we support the FSMA pro-activity.

L'autorité de surveillance des marchés financiers belge (la 'FSMA') a récemment multiplié les initiatives pour la protection des 'consommateurs financiers'. Elle a contribué à l'élaboration des règles légales nouvelles en cette matière, et a également émis des règlements, avertissements, circulaires et autres communications dans ce cadre. Une question mérite cependant d'être posée: cet activisme va-t-il à l'encontre de la sécurité juridique, de la compétitivité du secteur financier belge, et, dans une certaine mesure, des 'consommateurs financiers' eux-mêmes ? Nous tenterons d'y répondre en examinant les évolutions les plus récentes dans ce domaine au niveau (1) des obligations d'information précontractuelle et publicitaire, ainsi que des règles de responsabilité, contrôle et sanctions qui y sont liées, (2) de la 'gouvernance-produit' et (3) des 'pouvoirs d'intervention-produit'. Ces développements ont été introduits en droit belge par la réforme Twin Peaks II, le Livre VI du nouveau code de droit économique, l'arrêté royal transversal imposant un document d'information standardisé en cas de commercialisation aux investisseurs de détail, le règlement de la FSMA imposant un label de risque sur certains produits financiers et le règlement de la FSMA interdisant la commercialisation de produits financiers 'non-conventionnels' aux clients de détail. Nous conclurons par une prise de position critique sur les deux points d'attention majeurs du régulateur belge - les obligations d'information et 'l'intervention-produit'. Nous expliquerons qu'à notre avis une meilleure approche réglementaire serait de se concentrer sur la réglementation des intermédiaires financiers et la gouvernance-produit. Nous ne pouvons soutenir les initiatives de la FSMA que si elles vont dans ce sens. ; The Belgian financial supervisory authority (the Financial Services and Markets Authority or 'FSMA') pro-activity in recent months is striking. It drafted many rules and issued many regulations, warnings, circulars or other communications to increase the protection of clients who buy financial products on Belgian financial markets. But does the FSMA go too far too fast to the detriment of legal certainty, the competitiveness of the Belgian financial sector and, to some extent, financial clients themselves? This article tries to answer that question by examining some of the most recent developments in client protection on Belgian financial markets with respect to (1) provisions relating to pre-contractual and marketing information obligations, and related liability, supervision and sanction regimes, (2) product governance arrangements and (3) 'product intervention powers'. They were introduced in Belgian law by the 'Twin Peaks II package', Book VI of the new Code of economic law, the transversal marketing Royal decree, the FSMA label regulation, and the FSMA prohibition on the distribution of several non-mainstream financial products to retail clients. In the conclusions to this article, we give a critical assessment of the focus of the Belgian legislator on disclosure and product intervention. We explain that we favor point-of-sale regulation and product governance arrangements as regulatory approach to protect financial clients. Only to that extent do we support the FSMA pro-activity.

The Food Safety Modernization Act was a broadly impactful piece of legislation signed into law in 2011. This legislation is composed of seven core rules that together made sweeping changes to the regulations surrounding how foods are grown, harvested, and processed. These regulations affected many different industries, including the brewing industry and its supporting counterparts. Due to the expansive nature of the regulations, there have been issues with interpretations during their rollout and direct guidance from the FDA was not always immediately available. This meant that during initial years following passage of the legislation, non-government groups were left to gather information and disseminate answers to questions on maintaining compliance. A review of available literature and resources has found that even though there has now been clarification on how many of the provisions affect various industries directly from the FDA, resources on how to achieve compliance in specific areas are not always available and can sometimes be hidden behind a paid membership. Due to this, there exists a state where some resources may be unavailable to potential industry participants. There is value in providing free resources to potential participants, future research on sustainable practices with industry byproducts, and in identifying shortcomings in the legislative rollout for the benefit of future regulatory endeavors. ; MALS

The Food Safety Modernization Act (FSMA) was signed into law in the United States in 2011, shifting the existing food safety focus from a reactive to a preventive approach. According to literature, legislative requirements of FSMA can be challenging for small food facilities affected by the regulations immediately or in near future. Thus, the purpose of this research was to utilize quality management tools to identify and prioritize major challenges faced by small food facilities in adopting the preventive controls' component of the FSMA legislation. Data were collected using semi-structured interviews of food industry representatives and academic professionals from the Midwest region of the United States. An affinity diagram was used to identify the set of challenges that emerged from the interviews, following which a weighted multi-voting survey was used to prioritize the identified challenges. Major identified challenges included: understanding of the FSMA law, cost of implementation, timeline for implementation, employee preparedness, absence of quality culture, and employee willingness. Furthermore, a difference was observed in how industry representatives and academic professionals rank ordered the above-listed challenges.

During the 2017 annual meeting of the Western Regional Center to Enhance Food Safety, 52 representatives from 15 western states/territories, regional centers funded through USDA-NIFA Food Safety Outreach Program, federal and state government agencies, and non-governmental organizations prioritized topics for the Food Safety Modernization Act (FSMA) training materials that address region-specific agricultural production and processing systems. This article describes supplemental materials or "add-ons" developed to support FSMA-related food safety trainings. Although the materials were developed for the western region stakeholders, they can be applied or adapted to other regions in or outside the U.S. to enhance food safety trainings.

Between November 30 2010 and January 4 2011, the Food Drug and Administration (FDA) Food Safety Modernization Act (FSMA), or HR 2751, was passed through the US governing bodies, representing the first large-scale change in US food safety law since the 1930s. For three years, federal food safety law was discussed in over two dozen congressional hearings (Johnson, 2010a). The text has undergone multiple revisions and collaborative efforts: legislation concerning fresh fruit and vegetable produce alone received over 700 comments from hundreds of stakeholders (Gorny, 2011). Though the US food safety regime is one of the best in the world, there were telling signs of needed change. US consumers now spend 1 trillion USD on food per year (Johnson, 2010b). Increases in food safety concerns like food borne illness have gained global visibility and have lead to negative trade consequences (the recent fatal E. Coli outbreak in Germany exemplifying this quite clearly). Industry and public support for the Act was strong from the onset, yet some policymakers, private sector stakeholders, and small producers remain concerned about implementation, costs, equal opportunity, and market and price effects. This paper firstly gives reasons for the changes in food safety law and regulations in the US. A second section frames how food safety regulations are createdreviewing the challenges associated with science-based evidence, multi-actor expectations, and consumer knowledge. The paper discusses the current US regulations and how they will change in the coming years. Finally, the concerns raised about the implementation and regulatory design are reviewed, concluding with a short note on how these legislative changes may influence the data collected for the EU-NTM project. ; This paper was prepared for the project Analyzing the Effects from Non-Tariff Measures (NTM) in Global Agri-Food Trade, European Commission 7th Framework Program, Grant No. 227202.