Rulis A M
Office of Premarket Approval, Food and Drug Administration, Washington, DC 20204, USA.
Drug Metab Rev. 1996 Feb-May;28(1-2):197-208. doi: 10.3109/03602539608993999.
Today, safety evaluation of food ingredients must be performed for a wide spectrum of substances and over a wide range of potential human exposures. Some of the traditional approaches to toxicological safety evaluation are not appropriate for certain of the more extreme examples across this spectrum. Yet the public and the regulated industry continue, rightfully, to expect that the system will function efficiently and effectively in their behalf. FDA must expand the range of its available tools to address the unique questions presented by nontraditional food chemicals, while maintaining the scientific credibility and integrity of the regulatory decision process that has protected public health for many decades. The safety standard that these materials must meet has not changed. Yet the types of questions pertinent to safety decisions may indeed be different than those traditionally used.
如今，必须针对广泛的物质以及多种潜在的人体接触情况对食品成分进行安全性评估。一些传统的毒理学安全性评估方法并不适用于这一范围内某些更为极端的例子。然而，公众和受监管行业仍然合理地期望该系统能够高效且有效地代表他们发挥作用。美国食品药品监督管理局（FDA）必须扩大其可用工具的范围，以解决非传统食品化学品所带来的独特问题，同时保持监管决策过程的科学可信度和完整性，而这一过程已经保护公众健康数十年了。这些物质必须符合的安全标准并未改变。然而，与安全决策相关的问题类型可能确实与传统使用的问题不同。
