Hahn Martin J
Hogan Lovells US LLP, Washington DC, USA.
Food Drug Law J. 2010;65(2):217-30, i.
It now is possible to detect many substances in the parts per trillion and further advances will allow for even lower levels of detection. Many of these substances may always have been present in the food supply, but escaped detection. Others may have been introduced through environmental contamination, changes in food processing, sourcing of ingredients from different manufacturers or countries, and a myriad of other reasons. The adulteration and various safety provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), principles of statutory construction, and case law, provide FDA with the legal authority to adopt the threshold concept. FDA and the courts have long recognized it is possible to establish safe levels of poisonous or deleterious substances found in foods. FDA routinely conducts such an analysis under the general adulteration provisions of the FDCA and has identified safe levels for numerous environmental contaminants found in food. The courts have recognized that through its exercise of enforcement discretion, FDA has the legal authority to establish non-binding defect action levels for contaminants. FDA similarly could implement the Threshold of Toxicological Concern (TTC) through its exercise of enforcement discretion.
现在能够检测出万亿分之一含量水平的多种物质，而且未来的进一步发展将实现更低水平的检测。这些物质中的许多可能一直存在于食品供应中，但未被检测到。其他物质可能是通过环境污染、食品加工变化、不同制造商或国家的原料采购以及无数其他原因而引入的。《联邦食品、药品和化妆品法案》（FDCA）的掺假及各项安全规定、法律解释原则和判例法，赋予了美国食品药品监督管理局（FDA）采用阈值概念的法律权力。FDA和法院长期以来一直认识到，有可能确定食品中发现的有毒或有害物质的安全水平。FDA routinely根据FDCA的一般掺假规定进行此类分析，并已确定了食品中发现的多种环境污染物的安全水平。法院已经认识到，通过行使执法自由裁量权，FDA有权为污染物确定不具约束力的缺陷行动水平。FDA同样可以通过行使执法自由裁量权来实施毒理学关注阈值（TTC）。
