Safety historical concerns

Table 24.1 shows some representative numbers of these three risk measurements. One of the possibly surprising observations is that the chemical process industries are relatively safe (for workers) conpared witii many other industries. There are many reasons for this, ranging from the high level of remote sensing and operation, which separates workers from the most dangerous parts of the plant, to the historical concern for the hazards of industrial chemicals. Regardless of the reasons, chemical engineers continue to try to improve the safety of chemical plants. 

Historically, mine safety standards had been separate from the more general standards for occupational safety promulgated under the U.S. Occupational Safety and Health Administration (OSHA). In 1998, the Bureau of Mines was reorganized, and mine safety research was absorbed by the National Institute for Occupational Safety and Health (NIOSH). Bureau personnel were relocated to new projects—like diesel emissions—that seemed distant from the Bureau s historical concerns about dust, ventilation, ground control, and explosions. 

Workers in the metals treatment industry are exposed to fumes, dusts, and mists containing metals and metal compounds, as well as to various chemicals from sources such as grinding wheels and lubricants. Exposure can be by inhalation, ingestion, or skin contact. Historically, metal toxicology was concerned with overt effects such as abdominal coHc from lead toxicity. Because of the occupational health and safety standards of the 1990s such effects are rare. Subtie, chronic, or long-term effects of metals treatment exposure are under study. An index to safety precautions for various metal treatment processes is available (6). As additional information is gained, standards are adjusted. 

Another advantage cited for organic electronics is their perceived low environmental impact and high expected consumer safety. This assumption is generally based on the notion that plastics are easily recycled and are considered safe to humans and animals. However, the materials used are often completely new compositions with poorly understood health and safety attributes. The assumption that all plastics are completely safe for humans is inaccurate, as is exemplified by recent concerns about the toxicity of polyvinyl chloride (PVC).39 In contrast, most inorganic nanoparticle materials are already on the consumer market and have extensive historical data on their safety in a variety of applications. Some materials, such as zinc oxide, are even considered reasonably safe for ingestion and therefore are commonly used in food and cosmetics. However, the health effects and interactions of nanoparticles on the human body are still a topic of debate.40... 

The area of occupational toxicology has received a great deal of attention in the chemical industry. Historically, the chemical industry has focused on the occupational environment and developed many of our current toxicological methods to address health and safety concerns. However, since the mid-1970s the chemical industry has increasingly become subject to testing requirements relevant to the protection of the environment and the public at large, as mandated by Environmental... 

First considered an environmental issue (e.g., hazardous materials spills contaminating the environmental media—air, water, and/or soil), chemical facility safety has been an issue of congressional interest for many years. Review of the historical incidents listed in sidebar 4.1 provides some perspective on the magnitude of the consequences that might result from terrorist attacks. Obviously, these incidents (and others) increase concern over the potential for release of toxic chemicals and the associated potential health impacts on surrounding areas. 

This option assumes a comparable or even standard placebo response rate for historical data and the current trial. The historical improvement rate (on placebo or without any treatment) is then used for purposes of comparison with results of subsequent non-placebo-controlled studies involving the same investigator and protocol design but different drugs. For historical placebo response data it is recommended that a small placebo treatment arm is used for safety data purposes and to avoid observer bias although this proposal may resolve or diminish some ethical concerns, it raises a number of scientific problems ... 

There are a number of reasons to be concerned about the potential safety of such widespread use of CAHP. These products are frequently used by vulnerable populations, including older adults, those with chronic disorders, children, and women during pregnancy and lactation (5 10). These products are also used by patients to treat a variety of chronic disorders that are difficult to medically manage (e.g., anxiety, depression, dementia and memory impairment, headache, weight loss, back disorders, chronic pain, prostatic hypertrophy, and cancer) (1,11,12). Choice of a particular product for a particular condition is usually based on the claims made for the product and anecdotes of historical use, rather than conclusive scientific evidence that establishes the safety and efficacy of a particular product for a particular condition. 

Avoid questions in which you try to tie the Agency to a position based upon a precedent. The FDA is not required to consistently follow a historical position as conditions evolve, and prior actions of one part of the FDA do not create inviolate precedents incumbent on other parts. While there is an attempt by the Agency to maintain fairness and consistency, the fundamental issue always is human health and safety. Concerns emerging from differing conditions or from advances in the field will always trump consistency. 

Pharmacogenetics was historically most concerned with drug safety which will remain a concern, but the main effect of pharmacogenomics promises to be an improvement of drug efficacy. 

The viscose process has been abandoned progressively, but not totally, because of environmental concerns, as CS2 is toxic and can easily cause explosions. It remains, however, historically important in the field of the chemistry of cellulose. Besides, it must be noted that the viscose process has set standards of variety, quality and cost that any new process must at least equal, or even surpass. If not, the safety and environmental restrictions may cause the total abandonment of the viscose process worldwide. 

The conduct of toxicology studies in laboratory animals has been driven by experience, historical precedence, and governmental requirements, and the results of these studies usually, and reasonably, have led to restrictions on the use, or method of use, of the chemicals concerned [1], The primary objective of pharmaceutical preclinical safety evaluation is to provide information essential for the initiation of clinical trials. Scientific rationale and controlled reproducible data are used to show that the initial human risk is so low as to be ethically and practically acceptable in relation to the medical value of the information to be obtained from humans. Preclinical safety studies performed throughout the course of product development facilitate and may guide work... 

Mercury Manometers. A U-tube manometer filled with mercury is simple to construct, requires no calibration, and operates over a wide pressure range. It is now less frequently used due to concerns about safety hazards associated with mercury (see Appendix C) and its slow visual readout. However, it is a historically important device and it is directly related to barometers, which are discussed in Chapter XIX. 

Numerous concerns about the safety of hemoglobin preparations have been presented in the literature. Some of the historical safety concerns have been addressed and are no longer issues with respect to the hemoglobin formulations now in advanced clinical trials. For example, effects such as neutrophil and macrophage activation, the formation of microthrombi, and platelet aggregation appear to have been eliminated from these Hb formulations. However, new safety concerns, centering on effects that have been observed clinically, have been raised. Three principal concerns will be discussed here 1) Mb s pressor activity 2) the potential for acellular Hb to exacerbate injury and 3) the potential for Hb to potentiate or exacerbate infection. 

The use of lithium in psychiatry has varied historically. In the nineteenth century, lithium salts were employed in the treatment of anxiety, as well as gout and seizures. The importance of lithium s antimanic actions was indirectly discovered, in 1949, with observations that it produced a calming effect in animals. Human testing in agitated or manic patients followed, with encouraging results. However, lithium s use did not gain acceptance in American medicine until 1970, due to safety concerns... 

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