tissues, and recombinant therapeutic proteins. These products are regulated by the U.S. Food and Drug Administration (FDA).
Codex Alimentarius Commission: The Codex Alimentarius Commission is a subsidiary body of the Food and Agriculture Organization of the United Nations and the World Health Organization. The Commission is entrusted with the elaboration of international standards of food to protect the health of consumers and to ensure fair practices in the food trade.
Codex committees: These subsidiary bodies of the Codex Alimentarius Commission include 9 general subject committees, 15 specific commodity committees, 6 regional coordinating committees, and time-limited ad-hoc Intergovernmental Task Forces on specific subjects.
Critical control point: A step at which control is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Discriminatory strict liability: Holds those who import and sell foreign products in the United States legally liable for regulatory violations pertaining to goods. It mandates more severe penalties for violations related to imports than domestically produced goods. Under this form of liability importers and sellers may be found liable for issues with products even if they took appropriate safety precautions and were unaware that the product is unsafe (Bamberger and Guzman, 2008).
Drug regulation: Encompasses a variety of functions, such as licensing, inspection of manufacturing facilities and distribution channels, import and export controls, product assessment and registration, pharmacovigilance, quality control, control of drug promotion, and advertising and control of drug clinical trials.
Economies of scale: Factors that cause the average cost of producing a product to fall as the volume of its output increases.
Enterprise risk management: Enterprise risk management is a discipline, by which an organization in any industry assesses, controls, exploits, finances, and monitors risks from all sources for the purpose of increasing the organization’s short- and long-term value to its stakeholders (Casualty Actuarial Society-Enterprise Risk Management Committee, 2003).
Epidemiology: The study of occurrence, distribution, and determining factors associated with the health and diseases of a population; the study of how often health events or diseases occur in different groups and why.