Food and Drug Administration Regulation of Food Safety

The FDA Food Safety Modernization Act (FSMA) is by all accounts the most sweeping and comprehensive update to U.S. food laws in seventy years, aiming to confront the reality that the nation's food supply has undergone fundamental shifts in its sources, distribution channels, and intermediate handlers. The law's intent is to prevent problems that can cause foodborne illness and enable the Food and Drug Administration (FDA) to keep a record of facilities processing food for sale in the United States, a mandate that expands FDA's already global regulatory activities. FSMA gives FDA broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods. Because the law specifically aims to update FDA authority in light of the reality of global food and food additive markets, Section 305 FSMA calls for FDA to develop a comprehensive plan to expand the “technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States.”

The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform to the US food safety laws in more than 70 years. The legislation, signed into law by President Obama on January 4, 2011, amended the Food, Drug, and Cosmetic Act in three principal ways. First, it provided the Food and Drug Administration (FDA) new enforcement powers and lower threshold for administrative actions. Second, it required the FDA to promulgate seven foundational rules. These rules fundamentally reshape the food safety landscape. Finally, FSMA integrated the relationships up and down the supply chain requiring supplier verification which can ensure compliance through cooperation and also compel it through the enhanced risk of private litigation. This chapter will explore the roots of FSMA, delve into the new provisions of the legislation and foundational rules, and also analyze the early progress enforcing FSMA as of 2017.

The long-awaited enactment of the FDA Food Safety Modernization Act (FSMA), the most significant amendment to the Federal Food, Drug, and Cosmetic Act in several decades, provides the Food and Drug Administration (FDA) with significantly enhanced jurisdiction to close some of the gaps in the domestic food safety system. The enhanced FDA authority, however, will have little impact on the shared governance system at the federal level that involves multiple agencies, as the Act does not address the U.S. General Accounting Office's (GAO) repeated calls for consolidation of the fragmented federal food safety system. Rather, the Act perpetuates the division of authority between the FDA and the U.S. Department of Agriculture (USDA), as well as the potential for jurisdictional gaps, overlaps and inefficiencies. Part I of this article explores not only the FSMA, but a second piece of federal legislation, the Healthy, Hunger-Free Kids Act of 2010, which inter alia provides support for serving locally grown food in the school lunch program. Part II provides a brief update on three ongoing food law issues: the Pelman v. McDonald's Corp. obesity litigation and associated local initiatives directed at the fast food restaurant industry, legal challenges to the raw almond pasteurization rule, and an update on the FDA's review of genetically engineered salmon. Part III explores in greater depth a series of public and private enforcement actions directed toward allegedly deceptive labeling.

In September 2011, the U.S. Food and Drug Administration (FDA) asked the Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in Section 204 of the FDA Food Safety Modernization Act (FSMA). IFT collaborated with representatives from more than 100 organizations-including the U.S. Dept. of Agriculture, state departments of agriculture and public health, industry, and consumer groups, as well as not-for-profit organizations-to implement the pilots. The objectives of the pilot projects were 1) to identify and gather information on methods to improve product tracing of foods in the supply chain and 2) to explore and evaluate methods to rapidly and effectively identify the recipient of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated or misbranded. IFT conducted evaluations to determine the impact of currently available technologies, types of data and formats, and the data acquisition process, as well as the use of technology on the ability to follow product movement through the supply chain. Results from the pilots found inconsistencies in the terminology, numbering systems, formatting, legibility, and occasionally the language that sometimes required IFT to contact the submitting firm to gain clarity, thus increasing the time required to capture data before any meaningful analysis could begin. However, the pilot participants appeared to have many of the tools and processes in place which are required to allow the capture and communication of critical track and trace information (such as, key data elements) at critical points of product transfer and transformation (such as, critical tracking events). IFT determined that costs associated with implementing a product tracing system can vary widely as determined by numerous factors: the size of the firm/facility, the method of product tracing already in use (manual or electronic), and the range of each firm's capabilities to implement or improve its product tracing system, to name a few. IFT found that there are several areas (such as uniformity and standardization, improved recordkeeping, enhanced planning and preparedness, better coordination and communication, and the use of technology) in which industry improvements and enhancements to FDA's processes would enable tracebacks and traceforwards to occur more rapidly. IFT developed 10 recommendations for FDA to consider for improving the state of system-wide food product tracing. The recommendations outlined in the report will enable FDA to conduct more rapid and effective investigations during foodborne illness outbreaks and other product tracing investigations, thus significantly enhancing protection of public health.

Early in January, officials of the Food and Drug Administration (FDA) proposed two new sets of food safety rules aimed at curbing foodborne illnesses. Those rules, which are open for comment through early April, will be used in implementing the FDA Food Safety Modernization Act (FSMA) of 2011, a landmark piece of legislation that grants increased authority to FDA to lay out and then enforce food safety measures (Microbe, March 2011, p. 108).

Review of water quality criteria for water reuse and risk-based implications for irrigated produce under the FDA Food Safety Modernization Act, produce safety rule

Chapter 32 - HACCP and other regulatory approaches to prevention of foodborne diseases

Chapter 35 - HACCP and Other Regulatory Approaches to Prevention of Foodborne Diseases

On January 4, my Pew colleagues and I applauded President Obama and the U.S. Food and Drug Administration (FDA) for releasing two sets of draft rules central to implementing the FDA Food Safety Modernization Act (FSMA), the first major update to our food safety laws in more than 70 years. The law signals a long-overdue shift in FDA’s food safety strategy. Instead of reacting to an outbreak after it occurs, the agency will focus on preventing illnesses before they happen. This emphasis on prevention should help strengthen food safety and reduce foodborne illnesses, which strike about 48 million Americans and are responsible for more than $77 billion in health-related costs each year. The administration has taken an important step, but it must do more. Important draft regulations focused on the safety of imported foods are still awaiting release. These rules, which include the creation of a new Foreign Supplier Verification Program, are especially important since about two-thirds of fruits and vegetables and 80 percent of seafood consumed in the United States come from abroad. Overall, imports account for as much as 15 percent of all food consumed in U.S. households—and that figure is growing about 10 percent annually.

British chef and food activist Jamie Oliver ignited a firestorm in January 2011 when he mentioned on the Late Show with David Letterman that castoreum, a substance used to augment some strawberry and vanilla flavorings, comes from what he described as “rendered beaver anal gland.”1 The next year, vegans were outraged to learn that Starbucks used cochineal extract, a color additive derived from insect shells, to dye their strawberry Frappuccino® drinks2 (eventually, the company decided to transition to lycopene, a pigment found in tomatoes3). Although substances like castoreum and cochineal extract may be long on the “yuck factor,”4 research has shown them to be perfectly safe for most people; strident opposition arose not from safety issues but from the ingredients’ origins. But these examples demonstrate that the public often lacks significant knowledge about the ingredients in foods and where they come from. This is not a new development; the public relationship to food additives has a long history of trust lost, regained, and in some cases lost again. The Federal Food, Drug, and Cosmetic (FD&C) Act of 19385 was passed shortly after the deaths of 100 people who took an untested new form of a popular drug, which contained what turned out to be a deadly additive.6 The new law was consumer oriented and intended to ensure that people knew what was in the products they bought, and that those products were safe. The law has been amended over the years in attempts to streamline and bring order to the sprawling task of assessing and categorizing the thousands of substances used in foods, drugs, and cosmetics. One result of this streamlining is that under current U.S. law, companies can add certain types of ingredients to foods without premarket approval from the thin-stretched Food and Drug Administration (FDA). In other words, there are substances in the food supply that are unknown to the FDA. In 2010 the Government Accountability Office (GAO) concluded that a “growing number of substances … may effectively be excluded from federal oversight.”7 Is this a problem? The answer depends on whom you ask.

SummaryFood safety standards for the production of fruit and vegetables that are developed and administered by private sector actors have become a common requirement for producers and exporters of fresh produce in the past two decades. Instead of relying on inspection after produce has been harvested, preventive controls identify sources of food safety risks and introduce procedures to eliminate them or reduce them to acceptable levels. This approach has been criticised for its reliance on controls over the way food is produced and the use of third‐party certification to monitor and enforce compliance. The criticisms frequently imply that public controls over production and trade of fresh produce are less onerous and more science‐based. The FDA Food Safety Modernization Act (FSMA), passed by the US Congress in January 2011, adds a new element to the discussion of private standards. In a radical departure from past practice it introduces mandatory on‐farm preventive controls on US farms for those categories of fresh produce for which the risks to human health from food borne illness outbreaks are considered substantial. Food imported into the United States must be shown to have been produced to an equivalent level of safety, and the responsibility to verify this is placed on food importers. The use of preventive controls backed up by audit and inspection moves US public regulations much closer to the approach used by private standards developers and adopters.This paper compares and contrasts the development of private standards in Europe and the approach developed by the FSMA. It uses the framework of different regulatory strategies – performance‐based, technology‐based and management based – to analyse the regulatory choices made in both cases and their implications for producers and exporters in developing countries. It argues that the adoption of mandatory on‐farm controls by the FSMA reflects the seriousness of microbial contamination of fresh produce as a food safety risk and the shortcomings of performance‐based regulation. The impacts on exporters will be similar to the impact of private standards. The nature of these impacts will depend, first, upon the choice of on‐farm controls by the FDA for domestic production in the United States and the balance between technology‐based and management‐based regulation. The second factor is how the FDA will determine whether private standards and public regulations in exporting countries provide an equivalent level of safety to that in the US.

The US Food and Drug Administration (FDA) is a remarkable hybrid. Part regulatory agency, part public health agency, it sits at the intersection of science, law, and public policy. The FDA’s mission can be considered in the context of 2 broad dimensions: the products it regulates and its core functions. Both fall under the rubric of protecting and promoting the public health. The FDA’s remit is both broad and diverse: altogether, the agency has regulatory responsibility for >20% of the US economy. The products it is charged with overseeing through its various centers1 encompass food and cosmetics (regulated by the Center for Food Safety and Applied Nutrition); food and drugs for animals, including companion animals and animals used for food (regulated by the Center for Veterinary Medicine); and medical devices, drugs, and biologics (regulated by the Centers for Devices and Radiological Health, Drug Evaluation and Research, and Biologics Evaluation and Research, respectively). Tobacco products were added to the FDA’s portfolio by the Tobacco Control Act of 2009, and are overseen by the Center for Tobacco Products. Regardless of the specific product regulated, the FDA’s core mission remains the same: to protect the US population by helping to ensure the fundamental safety of the food Americans consume and the medical products prescribed by their clinicians. At the same time, this primary mission is complemented by a mandate to promote the public health by reviewing research and taking appropriate action on the marketing of regulated products in a timely manner. Not only do people need access to advances in nutrition and medical therapies, but also the American spirit is itself characterized by a strong current of scientific and technological innovation. At first glance, differences in these 2 priorities, protecting the public safety and promoting the public health through encouraging innovation, might …

Private standards relating to food safety have become an important element in trade in fresh fruit and vegetables, particularly in Europe. Discussions of the positive and negative impacts of such standards on farmers in developing countries are associated with the way they are implemented and enforced, with particular emphasis being placed on how these standards introduce prescriptive controls at the farm level backed up by audit and third‐party certification. Enactment in the United States of the FDA Food Safety Modernization Act (FSMA) in January 2011 adds a new element to the discussion of private standards. The Act mandates the introduction of risk‐based controls on domestic farms for fruits and vegetables deemed high risk. It also places an obligation on food importers to ensure that their suppliers observe equivalent levels of safety controls. The FSMA is likely to lead to farm‐level controls and certification as seen with private food safety standards as they have developed in Europe.

Closing gaps for performing a risk assessment on Listeria monocytogenes in ready‐to‐eat (RTE) foods: activity 2, a quantitative risk characterization on L. monocytogenes in RTE foods; starting from the retail stage

Food safety shake-up needed in the USA