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.

FDA

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 Act seeks to protect public health more effectively by strengthening the food safety system. FSMA focuses on preventing food safety problems before they occur and recognizes the importance of strong foodborne illness and outbreak surveillance systems. 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, as well as inspection and response.

USDA

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. In 2014, the Department of Homeland Security urged all areas of the U.S. government that worked with infective agents to take long-term steps to enhance safety and security.

The United States takes biosafety and biosecurity very seriously. As a result of lapses in biosafety practices that were discovered/came to light in the summer of 2014, Assistant to the President for Homeland Security and Counterterrorism Lisa Monaco and Assistant to the President for Science and Technology John Holdren issued on August 18, 2014 a memorandum, entitled, “Enhancing Biosafety and Biosecurity in the United States,” which urged all United States Government departments and agencies that work with infectious agents to take immediate and long-term steps to enhance safety and security of research to minimize the potential for future incidents. All United States government departments and agencies that possess, use, or transfer human, animal, or plant infectious agents or toxins were urged to perform a Safety Stand-Down, to include an immediate sweep of their facilities to verify that all Biological Select Agents and Toxins in their possession were appropriately registered, stored, and disposed of in accordance with applicable regulations.

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. As established in Homeland Security Presidential Directive-7 (HSPD-7, 2003) the Secretary of Homeland Security is responsible for coordinating the overall national effort to enhance the protection of the critical infrastructure and key resources of the United States. The Secretary of Homeland Security shall serve as the principal Federal official to lead, integrate, and coordinate implementation of efforts among Federal departments and agencies, State and local governments, and the private sector to protect critical infrastructure and key resources. This directive shall be implemented in a manner consistent with HSPD-7.

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.

State Involvement in Biosecurity

States play a critical role in biosecurity within agricultural law, as they are responsible for implementing and enforcing regulations related to the prevention, control, and eradication of agricultural diseases and pests within their borders. Some of the roles that states have in biosecurity in agricultural law include:

1. Implementing disease surveillance programs: States are responsible for implementing surveillance programs to detect and monitor the presence of diseases and pests that pose a threat to agricultural production. These programs may involve routine testing and inspection of animals, crops, and agricultural products to identify any signs of disease or pest infestations.
2. Developing and enforcing quarantine measures: States have the authority to establish and enforce quarantine measures to prevent the spread of diseases and pests. Quarantine measures may involve restricting the movement of animals or products in and out of an affected area or requiring that certain biosecurity protocols be followed to prevent the spread of disease.
3. Managing disease outbreaks: When an outbreak of a disease or pest occurs, states are responsible for coordinating the response efforts to control and contain the outbreak. This may involve implementing emergency measures such as depopulation, vaccination, or disinfection of affected areas.
4. Enforcing regulations related to biosecurity: States are responsible for enforcing regulations related to biosecurity, such as regulations related to the transport of animals and agricultural products, the use of vaccines and other treatments, and the disposal of contaminated materials.

Overall, states serve as catalysts in protecting agricultural production from the threats posed by diseases and pests. Through the implementation and enforcement of biosecurity measures, states help to ensure the health and safety of animals and plants, as well as the economic viability of agricultural industries.

The following sources provide more information on the roles of states in biosecurity in agricultural law, including disease surveillance, quarantine measures, managing disease outbreaks, and enforcing regulations related to biosecurity.

USDA APHIS. (2021). Animal Health Surveillance. Retrieved from https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/monitoring-and-surveillance/SA_NAHSS

USDA APHIS. (2019). Quarantine and Movement. Retrieved from https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/cattle-disease-information/quarantine-movement

USDA APHIS. (2019). Emergency Management. Retrieved from https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/cattle-disease-information/emergency-management

National Conference of State Legislatures. (2018). State Laws and Regulations Governing Animal Disease Control. Retrieved from https://www.ncsl.org/research/agriculture-and-rural-development/state-laws-and-regulations-governing-animal-disease-control.aspx

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.