Publications: Food Safety

Produce Safety Rule Highlights

Sarah Catherine Copper, Staff Attorney; National Agricultural Law Center (original author, 2020)
Jana Caracciolo, Staff Attorney; National Agricultural Law Center (updated, 2021)

Under the Food Safety Modernization Act, FDA was tasked with creating science-based minimum standards to prevent contamination of produce on the farm. To achieve this goal, FDA issued the Produce Safety Rule which creates science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is intended to minimize the risk of serious illness from produce. This factsheet provides an overview of the major components of the rule and provides links to detailed guidance documents provided by FDA. Download this factsheet. Last Updated December 14, 2021


Meat Processing Laws in the United States: A State Compilation

Elizabeth Rumley, Senior Staff Attorney; National Agricultural Law Center
James Wilkerson, Research Fellow; National Agricultural Law Center
National Agricultural Law Center Staff

For people or companies interested in opening a meat slaughter and processing facility, there can be requirements ranging from health and sanitation to waste disposal to specific facility or building requirements.  Because the requirements can vary so much from place to place, it is really important to obtain the correct information before any final plans are made, which allows potential operators to manage risk appropriately.  The purpose of this resource is provide contact information to offices both with the United States Department of Agriculture, specifically the Food Safety and Inspection Service (“USDA-FSIS”) and with appropriate state authorities on a state-by-state basis.  Additionally, it provides the relevant statutes in those states that have a state meat inspection program in place. View this compilation. Posted: May 5, 2020


“Cottage Food” Laws

Peggy Hall, Associate Professor- Agricultural and Resource Law Program; Ohio State University Extension

Nearly every state in the United States has enacted laws that allow entrepreneurs to produce certain food products in the home or “cottage” with little or no regulatory oversight.  These state “cottage food” laws aim to recognize that foods such as baked goods, jams, dry mixes and candies are not potentially hazardous and pose low risk of food contamination.  Despite the common goal of easing food safety requirements for those who product nonpotentially hazardous foods, there is much variation in the approaches taken by the states.  This compilation presents the statutes and regulations for each state that has a cottage food or home-based food production law. View this compilation. Posted: April 15, 2019; updated October 12, 2022.


 

FSMA Animal Food Rule – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Control

John G. Dillard, Olsson Frank Weeda Terman Matz PC

A new section of the Food Safety Modernization Act (FSMA) required FDA to promulgate regulations that require animal food facilities that are required to establish and implement a food safety system that includes hazard analysis and risk-based preventive controls.  Major provisions of the final rule implementing this section include those discussing current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls, supply-chain controls, and staggered compliance timelines.  This article, prepared as a project of the National Agricultural and Food Law Consortium, discusses and analyzes the major provisions of that rule.  Download this articlePosted 6/1/17 



3rd Party Food Safety Audits

S. C. Seideman and R.L. Rainey University of Arkansas Cooperative Extension Service

One of the best tools for increasing food safety is the third party audit that evaluates certain production practices know to produce better fruits and vegetables. A third party audit is when a totally independent party visits the farm production area and evaluates the field and/or facility in terms of its ability to produce safety, quality foods. This factsheet address some of the issues and benefits that third party food safety audits can provide to growers of specialty crops both in Arkansas and across the rest of the country.    Download this article Posted September 28, 2012.



European Union Food Law Update – IV

Emilie H. Leibovitch Law Office of Emilie H. Leibovitch Brussels, Belgium

This European Union Food Law Update addresses significant changes in European Union (EU) food law that occurred between 2006 and early 2008. The update is different from previous ones, as it is organized by the subject areas addressed by the developments. The published regulations, proposals, cases, and other relevant news are thus incorporated under their corresponding topic headings.        Download this article. Posted: April 9, 2009.



United States Food Law Update – III

Michael T. Roberts Member, Agriculture and Food Law Practice Group Venable LLP Washington, DC

This update summarizes significant changes and developments in food law over the second half of 2000 and provides a starting point for scholars, practitioners, food scientists, and policymakers to better understand the shaping of food law in modern society.  Tracing the development of food law through these updates also builds an important historical context for the overall development of food law.  New developments in state law, while certainly important and deserving of attention, are beyond the scope of this update.    Download this article Posted: November 16, 2007



European Union Food Law Update – III

Nicole Coutrelis Attorney at Law, Coutrelis & Associates Brussels, Belgium and Paris, France

The purpose of this update is to present the main events that have taken place in the food law sector in the European Union (E.U.) in the second half of 2005. This update concentrates on fundamental topics and focuses on food and thus excludes from its scope questions regarding the management of agricultural products (Common Agricultural Policy, or CAP). The update is divided into four main sections: published regulations, pending draft regulations, cases, and other relevant news.    Download this article Posted: November 16, 2007



Introduction to Food Law in the People’s Republic of China

Michael T. Roberts Attorney at Law

The adequacy of the food regulation system in the People’s Republic of China (PRC) has captured attention worldwide following numerous high profile cases of food safety problems in Chinese exports.  Notwithstanding the dearth of primary and interpretative sources in English, this article seeks to facilitate an understanding of the regulation of food safety in China.  This article begins with a brief narrative of recent food safety issues in China and an overview of the legal system in China then introduces food law in China, with a particular focus on the regulation of food safety.  This analysis covers the administrative organization of government bodies that have authority over food safety and the substantive regulatory provisions that govern these government bodies and the safety of food product.  Finally, the most recent developments of food law in China are briefly described.    Download this article. Posted: November 16, 2007



Role of Regulation in Minimizing Terrorist Threats Against the Food Supply: Information, Incentives, and Penalties

Michael T. Roberts Attorney at Law

Measuring the effectiveness of the government’s response to the threat of food terrorism is not easy. Much has been written about the role of government regulation in reducing health risks. Rather than devise a regulatory construct specifically to address the threat of food terrorism, this article evaluates the government’s efforts, within the existing regulatory construct, to minimize the risk of food terrorism by focusing on the effectiveness of the government’s use of three regulatory tools: information, incentives, and penalties. This article concludes that there are inherent limitations and weaknesses of the food regulatory system.    Download this article. Posted: August 2, 2007



From the Farm to the Factory: An Overview of the American and European Approaches to Regulation of the Beef Industry

Crisaria S. Houston Visiting Instructor, Thurgood Marshall School of Law Texas Southern University

The United States and Europe have the Herculean task of regulating cattle and beef production in each of their many states and countries, respectively, and many factors must be covered in their regulatory schemes.  This article briefly describes the existing regulatory requirements under the U.S. and European systems and compares the two approaches.  In comparing the two systems, attention is concentrated on the quality of legislative drafting, the likelihood of implementation, the adequacy of consumer protection, the voluntary or compulsory nature of the measures, and the requirement of records retention.    Download this article Posted: June 23, 2006



Is a Picture Worth More Than 1,000 Words?  The Fourth Amendment and the FDA’s Authority to Take Photographs Under the Federal Food, Drug, and Cosmetic Act

Neal D. Fortin Attorney at Law Okemos, Michigan

The Food and Drug Administration (FDA) touches the lives of nearly every American every day.  Yearly, the FDA regulates over $1 trillion worth of products, which accounts for nearly twenty-five cents of every dollar spent by American consumers.  Consequently, the FDA’s regulatory authority provides a rich arena for legal commentary, one of which is the FDA’s authority to take photographs under the Federal Food, Drug, and Cosmetic Act, long an area of controversy in the food and drug field.  Two currents roil beneath the surface of this issue: the Fourth Amendment right against unreasonable searches and the scope of the FDA authority to inspect under FDCA.  Yet, a recent literature search revealed a solitary law review article addressing the issue.  To fill the gap, this article analyzes the FDA’s authority to take photographs during regulatory inspections.  It reviews the FDA’s regulatory authority to conduct establishment inspections and discusses the FDA’s administrative policy and the case law on the scope of the FDA’s authority to take photographs during administrative inspections.  In addition, this article argues that the lack of express authority to take photographs does not equate with the lack of legal clarity.    Download this article Posted: June 23, 2006



United States Food Law Update – II

Michael T. Roberts Research Professor of Law and Director, National Agricultural Law Center University of Arkansas School of Law

This update summarizes significant changes and developments in food law over the first half of 2000  and provides a starting point for scholars, practitioners, food scientists, and policymakers to better understand the shaping of food law in modern society.  Tracing the development of food law through these updates also builds an important historical context for the overall development of food law.  New developments in state law, while certainly important and deserving of attention, are beyond the scope of this update.    Download this article Posted: June 23, 2006



European Union Food Law Update – II

Nicole Coutrelis Attorney at Law, Coutrelis & Associates Brussels, Belgium and Paris, France

The purpose of this update is to present the main events that have taken place in the food law sector in the European Union (E.U.). This update concentrates on fundamental topics and focuses on food  and thus excludes from its scope questions regarding the management of agricultural products (Common Agricultural Policy, or CAP). The update is divided into four main sections: published regulations, pending draft regulations, cases, and other relevant news.    Download this article Posted: June 23, 2006



United States Food Law Update

Michael T. Roberts Research Associate Professor of Law and Director, National Agricultural Law Center         and Margie Alsbrook Founding Editor-in-Chief, Journal of Food Law & Policy

The one constancy about food law in the United States is change, especially in a rapidly-changing food industry.  Innovations in food technology, shifts in popular culture and tastes, concerns of safety and nutrition, pressures from international markets, all contribute to the changing landscape of food law.  These changes are reflected in new federal statutes, regulations, administrative decisions, and judicial decisions.  This update summarizes significant changes and developments in food law over the last half of 2004 in order to provide a starting point for scholars, practitioners, scientists, and policy-makers determined to understand the shaping of food law in modern society.    Download this article Posted:  August 26, 2005



European Union Food Law Update

Nicole Coutrelis Attorney at Law Coutrelis & Associes, Brussels, Belgium and Paris, France

The purpose of this update is to present the main events that have taken place each six months in the food law sector in the European Union.  This presentation will cover June through December 2004, but is not exhaustive.  This update will not include detailed discussions of regulations, such as authorizations of new additives for animal feed or registrations of new geographic names.  Instead, it will concentrate on fundamental topics and focus on food, which excludes from our scope questions regarding the management of agricultural products.  The update will be divided into four main sections: published regulations, pending draft regulations, cases, and other relevant news.    Download this article Posted:  August 26, 2005



Anatomy of the Government’s Role in the Recall of Unsafe Food Products

Michael T. Roberts Director The National AgLaw Center

The government does not have the authority to mandate a recall of unsafe food.  Recalls of unsafe food products are voluntarily conducted by food companies and are monitored by either the Food and Drug Administration (FDA) or the United States Department of Agriculture (USDA) through its branch agency, the Food Safety and Inspection Service (FSIS).  In a typical food recall, the recalling company and the government agency work together to evaluate the product and risk and to recover that product.  This article describes the government’s role in this voluntary food recall system.  This article first explains the need for an effective recall system to protect consumers from foodborne illnesses.  Next, this article describes the unique dual-government agency responsibility for food recall, the basis for the “voluntary” food recall, and the government’s specific responsibilities and roles in the voluntary food recall system.   Download this article. Posted:  Nov. 22, 2004



Legal Issues in Developing a National Plan for Animal Identification

Michael T. Roberts, Director Harrison M. Pittman, Staff Attorney The National Agricultural Law Center

The recent discovery in the United States of bovine spongiform encephalopathy, commonly referred to as mad cow disease, has accelerated efforts to implement a national identification program for animals.  This is no easy task, as funding, logistical, and legal concerns need to be resolved.  This article briefly reviews the efforts to develop a national animal identification program and frames the legal issues raised by some producers to such a program.    Download this article. Posted: Feb. 4, 2004