Bioterrorism is terrorism involving the intentional release or dissemination of biological agents. These agents include bacteria, viruses, insects, fungi, and/or toxins, and may be in a naturally occurring or a human-modified form, in much the same way as in biological warfare. Further, modern agribusiness is vulnerable to anti-agricultural attacks by terrorists, and such attacks can seriously damage economy as well as consumer confidence. The latter destructive activity is called agrobioterrorism and is a subtype of agro-terrorism.
Biosecurity refers to measures aimed at preventing the introduction and/or spread of harmful organisms intentionally or unintentionally outside their native range and/or within new environments. In agriculture, these measures are aimed at protecting food crops and livestock from pests, invasive species, and other organisms not conducive to the welfare of the human population. The term includes biological threats to people, including those from pandemic diseases and bioterrorism. The definition has sometimes been broadened to embrace other concepts, and it is used for different purposes in different contexts.
Biodefense refers to measures to restore biosecurity to a group of organisms who are, or may be, subject to biological threats or infectious diseases. Biodefense is frequently discussed in the context of biowar or bioterrorism, and is generally considered a military or emergency response term.
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of the U.S. people and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW).
The Animal and Plant Health Inspection Service (APHIS) is an agency of the United States Department of Agriculture (USDA) based in Riverdale, Maryland responsible for protecting animal health, animal welfare, and plant health. APHIS is the lead agency for collaboration with other agencies to protect U.S. agriculture from invasive pests and diseases. APHIS's PPQ is the National Plant Protection Organization for the U.S., and the agency's head of veterinary services/veterinary Deputy Administrator is the Chief Veterinary Officer of the United States.
The Canadian Food Inspection Agency is a regulatory agency that is dedicated to the safeguarding of food, plants, and animals (FPA) in Canada, thus enhancing the health and well-being of Canada's people, environment and economy. The agency is responsible to the Minister of Health.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a United States federal law that set up the basic U.S. system of pesticide regulation to protect applicators, consumers, and the environment. It is administered and regulated by the United States Environmental Protection Agency (EPA) and the appropriate environmental agencies of the respective states. FIFRA has undergone several important amendments since its inception. A significant revision in 1972 by the Federal Environmental Pesticide Control Act (FEPCA) and several others have expanded EPA's present authority to oversee the sales and use of pesticides with emphasis on the preservation of human health and protection of the environment by "(1) strengthening the registration process by shifting the burden of proof to the chemical manufacturer, (2) enforcing compliance against banned and unregistered products, and (3) promulgating the regulatory framework missing from the original law".
Under United States law, Biological select agents or toxins (BSATs)—or simply select agents for short—are bio-agents which have been declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety". The agents are divided into (1) HHS select agents and toxins affecting humans; (2) USDA select agents and toxins affecting agriculture; and (3) overlap select agents and toxins affecting both.
The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.
The Biomedical Advanced Research and Development Authority (BARDA)' is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases. BARDA was established in 2006 through the Pandemic and All-Hazards Preparedness Act (PAHPA) and reports to the Office of the Assistant Secretary for Preparedness and Response (ASPR). The office manages Project BioShield, which funds the research, development and stockpiling of vaccines and treatments that the government could use during public health emergencies such as chemical, biological, radiological or nuclear (CBRN) attacks.
The Virus-Serum-Toxin Act or VSTA was United States Federal legislation designed to protect farmers and livestock raisers by regulating the quality of vaccines and point-of-care diagnostics for animals. Initially, the Virus-Serum-Toxin Act was created due to significant losses from unregulated manufacture and distribution of anti-hog cholera serum. The Act's intended purpose is to ensure the safe and efficient supply of animal vaccines and other biological products. The United States Secretary of Agriculture is responsible for licensing and regulating the manufacture, importation, and exportation of affected agents. The act and its applicable guidelines are managed by the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA).
The Administration for Strategic Preparedness and Response (ASPR) is an operating agency of the U.S. Public Health Service within the Department of Health and Human Services that focuses preventing, preparing for, and responding to the adverse health effects of public health emergencies and disasters. Its functions include preparedness planning and response; building federal emergency medical operational capabilities; countermeasures research, advance development, and procurement; and grants to strengthen the capabilities of hospitals and health care systems in public health emergencies and medical disasters. The office provides federal support, including medical professionals through ASPR’s National Disaster Medical System, to augment state and local capabilities during an emergency or disaster.
On December 19, 2006, the Pandemic and All-Hazards Preparedness Act (PAHPA), Public Law No. 109-417, was signed into law by President George W. Bush. First introduced in the House by Rep. Mike Rogers (R-MI) and Rep. Anna Eshoo (D-CA), PAHPA had broad implications for the United States Department of Health and Human Services's (HHS) preparedness and response activities. Among other things, the act amended the Public Health Service Act to establish within the department a new Assistant Secretary for Preparedness and Response (ASPR); provided new authorities for a number of programs, including the advanced development and acquisitions of medical countermeasures; and called for the establishment of a quadrennial National Health Security Strategy.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a drug prior to approval. It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.
The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration (FDA) new authority to regulate the way foods are grown, harvested and processed. The law grants the FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires the FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.
Biosecurity in the United States is governed by the Bureau of Western Hemisphere Affairs, which is part of the US Department of State. It obtains guidance and advice on specific matters relating to biosecurity from various other government agencies.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.
The United States biological defense program—in recent years also called the National Biodefense Strategy—refers to the collective effort by all levels of government, along with private enterprise and other stakeholders, in the United States to carry out biodefense activities.
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 is a law enacted by the 113th United States Congress. The Act amends the Public Health Service Act in order to extend, fund, and improve several programs designed to prepare the United States and health professionals in the event of a pandemic, epidemic, or biological, chemical, radiological, or nuclear accident or attack. The Act clarifies the authority of different American officials, makes it easier to temporarily reassign personnel to respond to emergency situations, and alters the process for testing and producing medical countermeasures. The Act is focused on improving preparedness for any public health emergency.
Food defense is the protection of food products from intentional contamination or adulteration by biological, chemical, physical, or radiological agents introduced for the purpose of causing harm. It addresses additional concerns including physical, personnel and operational security.
