No-observed-adverse-effect Level
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No-observed-adverse-effect Level
The no-observed-adverse-effect level (NOAEL) denotes the level of exposure of an organism, found by experiment or observation, at which there is no biologically or statistically significant increase in the frequency or severity of any adverse effects of the tested protocol. In drug development, the NOAEL of a new drug is assessed in laboratory animals, such as mice, prior to initiation of human trials in order to establish a safe clinical starting dose in humans. The OECD publishes guidelines for Preclinical Safety Assessments, in order to help scientists discover the NOAEL. Synopsis Some adverse effects in the exposed population when compared to its appropriate control might include alteration of morphology, functional capacity, growth, development or life span. The NOAEL is determined or proposed by qualified personnel, often a pharmacologist or a toxicologist. The NOAEL could be defined as "the highest experimental point that is without adverse effect," meaning that under lab ...
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Organism
In biology, an organism () is any living system that functions as an individual entity. All organisms are composed of cells (cell theory). Organisms are classified by taxonomy into groups such as multicellular animals, plants, and fungi; or unicellular microorganisms such as protists, bacteria, and archaea. All types of organisms are capable of reproduction, growth and development, maintenance, and some degree of response to stimuli. Beetles, squids, tetrapods, mushrooms, and vascular plants are examples of multicellular organisms that differentiate specialized tissues and organs during development. A unicellular organism may be either a prokaryote or a eukaryote. Prokaryotes are represented by two separate domains – bacteria and archaea. Eukaryotic organisms are characterized by the presence of a membrane-bound cell nucleus and contain additional membrane-bound compartments called organelles (such as mitochondria in animals and plants ...
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Glasgow Caledonian University
Glasgow Caledonian University ( gd, Oilthigh Chailleannach Ghlaschu, ), informally GCU, Caledonian or Caley, is a public university in Glasgow, Scotland. It was formed in 1993 by the merger of The Queen's College, Glasgow (founded in 1875) and Glasgow Polytechnic (founded in 1991). In June 2017, the university's New York partner institution, which was founded in 2013, was granted permission to award degrees in the state, the first higher education institution founded by a foreign university to achieve this status. History The university traces its origin from ''The Queen's College, Glasgow'' (founded 1875), and the ''Glasgow College of Technology'' (founded 1971). The Queen's College, which specialised in providing training in domestic science, received the royal accolade of being named after Queen Elizabeth in its centenary celebrations in 1975. Queen Elizabeth was, herself, patron of the college since 1944. Glasgow Polytechnic, which was one of the largest central institut ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ...
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Food Safety
Food safety (or food hygiene) is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way, food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry to market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods ...
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Food Law
{{Commons category, Food law Law Law is a set of rules that are created and are enforceable by social or governmental institutions to regulate behavior,Robertson, ''Crimes against humanity'', 90. with its precise definition a matter of longstanding debate. It has been vario ... Law by issue Food politics ...
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Environmental Policy In The United States
The environmental policy of the United States is a federal governmental action to regulate activities that have an environmental impact in the United States. The goal of environmental policy is to protect the environment for future generations while interfering as little as possible with the efficiency of commerce or the liberty of the people and to limit inequity in who is burdened with environmental costs. As his first official act bringing in the 1970s, President Richard Nixon signed the U.S. National Environmental Policy Act (NEPA) into law on New Years Day, 1970. Also in the same year, America began celebrating Earth Day, which has been called "the big bang of U.S. environmental politics, launching the country on a sweeping social learning curve about ecological management never before experienced or attempted in any other nation." NEPA established a comprehensive US national environmental policy and created the requirement to prepare an environmental impact statement for “ma ...
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Concentration Indicators
In chemistry, concentration is the abundance of a constituent divided by the total volume of a mixture. Several types of mathematical description can be distinguished: '' mass concentration'', ''molar concentration'', ''number concentration'', and ''volume concentration''. The concentration can refer to any kind of chemical mixture, but most frequently refers to solutes and solvents in solutions. The molar (amount) concentration has variants, such as normal concentration and osmotic concentration. Etymology The term concentration comes from the word concentrate, from the French , from con– + center, meaning “to put at the center”. Qualitative description Often in informal, non-technical language, concentration is described in a qualitative way, through the use of adjectives such as "dilute" for solutions of relatively low concentration and "concentrated" for solutions of relatively high concentration. To concentrate a solution, one must add more solute (for example, a ...
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Measures Of Pollutant Concentration
Measures of pollutant concentration are used to determine risk assessment in public health. Industry is continually synthesizing new chemicals, the regulation of which requires evaluation of the potential danger for human health and the environment. Risk assessment is nowadays considered essential for making these decisions on a scientifically sound basis. Measures or defined limits include: * ''no-observed-adverse-effect level'' (NOAEL), also called ''no-effect concentration'' (NEC), ''no-observed-effect concentration'' (NOEC) or similarly * ''lowest-observed-adverse-effect level'' (LOAEL) * ''acceptable operator exposure level'' (AOEL) * ECx (in percentage). No-effect concentration ''No-effect concentration'' (NEC) is a risk assessment parameter that represents the concentration of a pollutant that will not harm the species involved, with respect to the effect that is studied. It is often the starting point for environmental policy. There is not much debate on the existence o ...
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Lowest-observed-adverse-effect Level
The lowest-observed-adverse-effect level (LOAEL), or the lowest-observed-adverse-effect concentration (LOAEC), is the lowest concentration or amount of a substance found by experiment or observation that causes an adverse alteration of morphology, function, capacity, growth, development, or lifespan of a target organism distinguished from normal organisms of the same species under defined conditions of exposure. Federal agencies use set approval standards below this level. The United States Environmental Protection Agency defines LOAEL as the 'lowest level of a chemical stressor evaluated in a toxicity test that shows harmful effects on a plant or animal. While LOAELs and LOAECs are similar, they are not interchangeable. A LOAEL refers to a dose of chemical that is ingested, while a LOAEC refers to direct exposure to a chemical (e.g., through gills or the skin). See also *No-observed-adverse-effect level *Reference dose A reference dose is the United States Environmental Protectio ...
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United States Environmental Protection Agency
The Environmental Protection Agency (EPA) is an independent executive agency of the United States federal government tasked with environmental protection matters. President Richard Nixon proposed the establishment of EPA on July 9, 1970; it began operation on December 2, 1970, after Nixon signed an executive order. The order establishing the EPA was ratified by committee hearings in the House and Senate. The agency is led by its administrator, who is appointed by the president and approved by the Senate. The current administrator is Michael S. Regan. The EPA is not a Cabinet department, but the administrator is normally given cabinet rank. The EPA has its headquarters in Washington, D.C., regional offices for each of the agency's ten regions and 27 laboratories. The agency conducts environmental assessment, research, and education. It has the responsibility of maintaining and enforcing national standards under a variety of environmental laws, in consultation with state, tr ...
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Risk Assessment
Broadly speaking, a risk assessment is the combined effort of: # identifying and analyzing potential (future) events that may negatively impact individuals, assets, and/or the environment (i.e. hazard analysis); and # making judgments "on the tolerability of the risk on the basis of a risk analysis" while considering influencing factors (i.e. risk evaluation). Put in simpler terms, a risk assessment determines possible mishaps, their likelihood and consequences, and the tolerances for such events. The results of this process may be expressed in a quantitative or qualitative fashion. Risk assessment is an inherent part of a broader risk management strategy to help reduce any potential risk-related consequences. Need Individual risk assessment Risk assessment are done in individual cases, including patient and physician interactions. Individual judgements or assessments of risk may be affected by psychological, ideological, religious or otherwise subjective factors, which impa ...
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