Agricultural Biosecurity – An Overview

Events from recent decades, specifically the attacks of September 11 and the discovery of a cow with BSE, have contributed to concerns about potential vulnerabilities in the United States’ agriculture and food sectors to dangerous pathogens and agents either intentionally or unintentionally introduced into the system.  To address this threat, Congress, the White House, federal agencies and state governments have bolstered current food safety and security regimes and created some new regulatory authority.  The resulting system involves numerous agencies with varied responsibilities in ensuring the security of the agricultural and food system, with the primary agencies being the Food and Drug Administration (FDA), Department of Agriculture (USDA), and Department of Homeland Security (DHS).  For more information on the traditional food safety regulatory scheme, see the Food Safety Reading Room.


The Public Health Security and Bioterrorism Preparedness Response Act of 2002 (Bioterrorism Act) was signed into law in 2002 and affects the authorities of numerous agencies, including FDA, USDA, and DHS.  The Act provides FDA with the responsibility of protecting the safety and security of the food and drug supply, with the major exceptions of meat, poultry, and processed eggs.  In exercising this responsibility, FDA now requires all facilities that process, package, or hold food for consumption to register with the FDA, keep records of where food in their possession came from and where it was delivered, and provide FDA prior notice of imported food shipments.  The term “facilities” includes foreign firms but does not include farms, restaurants, retail food establishments, or fishing vessels.  FDA also has the authority to detain food if credible evidence exists that the food presents a serious threat to humans or animals.  The FDA also monitors the animal feed industry to ensure the safety of animals.

The Food Safety Modernization Act of 2011 (FSMA) further expanded the FDA’s authority to regulate the way food is grown, harvested, and processed. The FSMA granted the FDA with several new powers, including mandatory recall authority. While previous food safety statutes had focused on what to do after a safety problem occurred, the FSMA focuses on preventative measures.


The Bioterrorism Act provides USDA oversight responsibilities over agents or toxins deemed to be a threat to animal or plant health.  USDA requires entities that possess, use, or transfer these agents to register with USDA Animal and Plant Health Inspection Service (APHIS).  In a parallel provision, entities that possess those agents or toxins that could threaten public health must also register those agents.  APHIS is also charged with enforcing the Animal Health Protection Act, which requires USDA to prevent, detect, control, and eradicate animal diseases by doing such things as seizing, quarantining, and disposing of diseased animals.  APHIS is also establishing the National Animal Identification System (NAIS), which will allow animal and public health officials to record the history of animal movements so these officials can determine the path of disease.  To learn more about NAIS, please visit the Animal Identification Reading Room.  As part of its authority over the food safety of meat, poultry, and processed eggs, USDA Food Safety Inspection Service is now tasked with ensuring the security of those products.

Department of Homeland Security

The Homeland Security Act also has a number of provisions addressing the security of the agricultural and food sector.  The Department of Homeland Security conducts scientific research and works with the broader scientific community to protect against agroterrorism.  DHS now has the responsibility of inspecting animals and food imported into the United States.  DHS has authority to implement Support Anti-Terrorism by Fostering Effective Technologies Act of 2002 (SAFETY Act), which is intended to encourage the development, manufacturing, and use of protective technology and services, by providing limited immunity from liability for vendors and buyers of certified products or services.

Presidential Directive

In early 2004, the White House provided a Presidential Directive establishing a national policy to defend the agriculture and food system from terrorist attacks, major disasters, and other emergencies.  The directive tasks the Secretary of Homeland Security with coordinating the efforts of federal departments and agencies, State and local governments, and the private sector to protect all critical infrastructures, including the agriculture and food system.  The directive also looks to USDA, EPA, FDA and other agencies to carry out the responsibilities related to the directive.  These responsibilities range from increasing awareness of threats, assessing vulnerabilities, mitigating risk, and planning for responses and recovery from incidents.

Critical Infrastructure

The food and agriculture sectors were deemed part of the nation’s critical infrastructure by the National Strategy for Homeland Security, which was issued in July 2002.  Critical infrastructure is defined as those “systems and assets, whether physical or virtual, so vital to the United States that the incapacity or destruction of such systems and assets would have a debilitation impact on security, national economic security, national public health or safety, or any combination of those matters.”  The Homeland Security Act provides that information related to a “critical infrastructure” that is voluntarily submitted to DHS for homeland security purposes shall be exempt from the Freedom of Information Act.  This provision also states that the information shall not be used by any federal agency in any civil action.