Trace and traceability—a call for regulatory harmony
Trace and traceability—a call for regulatory harmony
复制标题
DOI：
10.1038/nbt0908-975
复制
发表时间：
2008-09
影响因子：
46.9
通讯作者：
K. Ramessar;T. Capell;R. Twyman;H. Quemada;P. Christou
中科院分区：
文献类型：
--
作者：
K. Ramessar;T. Capell;R. Twyman;H. Quemada;P. Christou
2007年，转基因作物在23个国家商业化种植，另有29个国家允许进口转基因作物用于食品和/或饲料用途，并释放到环境中1。尽管有令人鼓舞的证据表明，采用转基因技术带来了积极的社会经济和环境效益1，2，但我们希望强调的是，由于与研究、生物安全以及转基因作物的贸易和使用有关的国家监管框架之间缺乏协调，进一步的发展受到阻碍。这一点在管理非转基因食品中转基因物质容许水平的法律和法规以及转基因产品的标签和可追溯性方面表现得最为明显。转基因和非转基因食品的定义因国家而异，有些国家在转基因法规中规定了精确的容忍目标，有些国家则忽视了这一重要标准。欧洲联盟（EU;布鲁塞尔）遵循“预防措施”和消费者的“知情权”，对任何由转基因成分生产或衍生的食品都有严格的批准、标签和可追溯性标准3。相比之下，美国的法规是基于最终产品的差异，并包括自愿安全咨询和转基因食品自愿标签指南4。大多数其他发达国家，包括日本、加拿大、澳大利亚和新西兰，都引入了具有欧盟和美国制度特点的法规4。发展中国家往往将其监管框架建立在发达国家推广的模式基础上，而不考虑此类决定的潜在社会经济影响，以及过于谨慎的监管环境对其人口健康和福祉的负面影响。表1对选定国家的监管框架进行了比较。在美国和加拿大，以及日本和台湾，食品和饲料可以被归类为非转基因，即使它们含有高达5%的转基因材料。相比之下，其他国家设定的限制要低得多（例如，欧盟为0.9%，澳大利亚、新西兰、南非、巴西和中国为1%）。欧盟实际上有一个两级容忍政策，0.9%的限制适用于已批准的转基因生物，更严格的0.5%的限制适用于尚未批准的转基因生物，但已获得有利的风险评估。在许多发展中国家，似乎没有确定的耐受限度，这就引起了人们对这些国家如何区分转基因和非转基因食品和饲料的疑问。同样，这种全球监管上的不一致引发了一个问题，即从高耐受性国家进口的名义上不含转基因的食品和饲料在可能违反当地有关转基因耐受性的法规时，将如何在更严格的国家处理。这必然会
Genetically modified (GM) crops were grown commercially in 23 countries in 2007, with a further 29 allowing the import of GM crops for food and/or feed use and release into the environment1. Despite encouraging evidence concerning the positive socioeconomic and environmental benefits brought about by the adoption of GM technology1, 2, we wish to highlight the fact that further development is being hampered by a lack of harmonization among national regulatory frameworks relating to research, biosafety and to the trade and use of GM crops. Nowhere is this more apparent than in the laws and regulations governing the tolerance levels for GM material in non-GM food and in the labeling and traceability of GM products. The definition of what is considered GM and non-GM food varies from country to country, with some nations enshrining precise tolerance targets in their GM regulations and some overlooking this important criterion. The European Union (EU; Brussels) follows the ‘precautionary approach’and the consumers’‘right to know’, with stringent approval, labeling and traceability standards on any food produced from or derived from GM ingredients3. In contrast, US regulations are based on differences in the end product, and include a voluntary safety consultation and voluntary labeling guidelines for GM food4. Most other developed countries, includingJapan, Canada, Australia and New Zealand, have introduced regulations that share features of both the EU and US systems4. Developing countries often base their regulatory frameworks on models promoted by developed nations without considering the potential socioeconomic impact of such decisions, and the negative consequences of an overcautious regulatory environment on the health and well-being of their populations. The regulatory frameworks of selected countries are compared in Table 1. In the United States and Canada, as well as Japan and Taiwan, food and feed can be classed as non-GM, even if they contain up to 5% GM material. In contrast, other countries set much lower limits (eg, 0.9% in the EU or 1% in Australia, New Zealand, South Africa, Brazil and China). The EU actually has a two-tier tolerance policy, with the 0.9% limit applied to approved GM organisms, and a stricter 0.5% limit applied to GM organisms that have yet to be approved, but which have received favorable risk assessments. In many developing countries, there appears to be no established tolerance limit, which calls into question how such countries will distinguish GM and non-GM food and feed. Similarly, this global regulatory discord begs the question of how nominally GM-free food and feed imported from countries with high tolerance will be handled in stricter countries when it may breach local regulations concerning GM tolerance. This inevitably will