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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.

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

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.

Food systems worldwide have experienced a significant level of integration in recent decades, creating a global and dynamic food supply. In the US, imports amount to 15% of the American diet and nearly doubled in value during the last decade, reaching $90 billion in 2008. If food imports satisfy a growing domestic demand, they also pose formidable regulatory challenges when it comes to safety. A global food supply may introduce in domestic systems new, non-endemic risks, re-introduce risks that were controlled and rapidly spread contamination across borders. Recent food scares caused by imported foods have highlighted the vulnerabilities of the US food safety system in addressing the risks posed by a global food supply and increased public and private demands for food safety. In January 2011, President Obama signed into law the FDA Food Safety Modernization Act, a comprehensive reform bill promising to significantly improve the US food safety system and introduce new instruments to minimise risks at home and abroad. The objective of this article is to understand how a major world economy is responding to the import safety challenge and what institutions and regulations are emerging to ensure the safety of a global food chain. We do so by analysing the new legislation to identify the policy approaches chosen and evaluate their promise and pitfalls. In the absence of a general theoretical model defining an optimal regulatory mix to promote food import safety, our analysis was informed by recent studies on the challenges of import safety as well as research on specific aspects of food safety regulatory policy that we encountered in the reform bill. The results of our analysis highlight a four-pronged approach in the reform bill based on (1) risk-based interventions and prevention; (2) information management and record keeping; (3) third-party certification; and (4) international activities. Several provisions extend the US authority to carry out enforcement and other activities in exporting countries, raising concerns about extraterritorial jurisdiction. Additionally, the reform institutionalises a growing trend where food safety governance derives from public and private regulations. Although reliance on private regulation may be desirable given the advances in safety controls in the private sector, regulators should exercise caution and set up adequate incentives and checks to avoid problems of conflicts of interest and capture.

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.

The United States' Food Safety Modernization Act (FSMA) revises the US Food and Drug Administration's regulatory authority. While expanding FDA's authority, the legislation replicates and relies on private systems of standards and third party audits, albeit with modifications. This article argues that public and private actors develop food safety regulations within multiple types of institutional venues, including private standards regimes, courts, congresses, and government regulatory agencies. It examines how interactions within each of these venues are shaped by stakeholders' interests, and how the relevant subset of interactions within these venues ultimately shaped the FSMA. The article concludes by offering insights into what consequences these interactions and outcomes may have on the roles and capacities of affected stakeholders in food safety governance.