Toxic materials history

F. Common toxic materials of frequent concern that are commonly addressed in the occupational exposure history... 

Based on the history of terrorist attacks, which have mostly involved hijacking and bombing of aircraft, current threat-detection measures have concentrated on detecting weapons or explosives. In the future, terrorist attacks could also involve the use of toxic chemicals, chemical and biological warfare agents, or even radiological and nuclear materials.1 2... 

All of these chemicals pose an inhalation hazard but a toxic dose could also be obtained through skin absorption or ingestion. Factors that were considered when selecting potential candidate chemicals include global production, physical state of the material (i.e., gas, liquid, or solid), chemicals likely to cause major morbidity or mortality, potential to cause public panic and social disruption, chemicals that require special action for public health preparedness, history of previous use by the military, and/or involvement in a significant industrial accident. 

Hazard assessment. A hazard assessment is required to assess the potential effects of an accidental (or intentional) release of a covered chemical/material. This RMP element generally includes performing an off-site consequence analysis (OCA) and the compilation of a five-year accident history. The OCA must include analysis of a least one worst-case scenario. It must also include one alternative release scenario for the flammables class as a whole also each covered toxic substance must have an alternative release scenario. USEPA has summarized some simplified consequence modeling... 

Nagaveni K, Silalingam G, Hegde MS, Madras G (2004) Photocatalytic degradation of organic compounds over combustion-synthesized nano TiO. Environ Sci Technol 38 1600-1604 Naiiagu JO (1996) History of global metal pollution. Science 272 223-224 Nel A, Xia T, Madler L, Li N (2006) Toxic potential of materials at the nanolevel. Science 311 622-627... 

On December 3, 1984, a toxic gas release from a pesticide plant in India killed nearly 3000 people and injured at least 100,000 others. The chemical that leaked was methyl isocyanate, a chemical intermediate that was supposed to be stored in a cooled bunker near the plant s outer boundary. The vapor is highly toxic and causes cellular asphyxiation and rapid death. Despite engineering and procedural provisions to prevent its release, a total system breakdown resulted in the release of 40 tons of the deadly material into the densely populated community of Bhopal. Because of this incident, the plant was dismantled and ultimately the parent corporation. Union Carbide, was forced to make a number of organizational changes. The occurrence is considered by many to have been the most tragic chemical accident in history. 

Representative samples of each shipment must be collected for testing as required by 211.84. (b). The number of containers to be sampled depends on the (i) component variability, (ii) confidence level, (iii) degree of precision desired, (iv) past quality history of the supplier, and (v) quantity needed for analysis and reserve samples. For hazardous or highly toxic raw materials, where on-site testing may be impractical, suppliers COA should be obtained, showing that the raw materials conform to specifications. In addition, the identity of these raw materials should be confirmed by examination of containers and labels. The lack of on-site testing for hazardous raw materials should be documented. 

In the case of noncompendial materials, specifications and complete descriptions of the test methodologies to be used for quality control release purposes by the sponsor should be included. In addition, it may be necessary for the sponsor to obtain a letter authorizing reference to a DMF from the supplier concerning the manufacturing and controls procedures used to make these materials, such as mixtures of colorants or flavors. It may be necessary to obtain toxicity data if the mixture or component has little or no history of human use (e.g., new polymers). If it is anticipated that an untried component will be used, it is recommended that discussions be initiated with the FDA s reviewing chemist and pharmacologist. These sessions should be scheduled as soon as possible to minimize the possibility of delays in NDA approval caused by inadequate information to support use of the material. 

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