河豚肉质鲜美，为鱼中珍品，在我国有几千年食用历史。但因其体内含有河豚毒素（TTX），是一种剧毒生物碱，其毒力是氰化钾的1250倍，加工处理不当或误食常可引起中毒，甚至丧生，故有“拼死食河豚”之说，所以一直以来我国的法律都禁止食用河豚鱼。近年来随着养殖控毒技术的发展，通过科学方法养殖的河豚鱼已达到安全控毒甚至无毒级别。日前国家卫生计生委通过安全性评价发出征求意见公告，拟批准养殖红鳍东方鲀和养殖暗纹东方鲀作为新食品原料。可以预期，一旦养殖河豚鱼作为新食品原料被批准后将极大激活国内消费市场。但是，个体捕捞野生河豚鱼或公告以外的河豚鱼品种，势必也会混入餐桌，给河豚鱼食用安全带来了潜在风险。由于河豚经营者和消费者没有识别野生有毒河豚与养殖河豚的能力，河豚鱼加工的餐饮服务单位能力参差不齐，尤其是我国还缺乏相关规范标准，为生产经营者及食品安全监管部门提供依据，这些现状都给消费者带来极大的安全隐患。 本研究课题主要为解决养殖河豚鱼被批准食用后监管环节可能面临的食品安全突出问题，针对目前的法律法规和标准体系的不完善、加工操作规范缺乏、以及在养殖、生产、流通和餐饮服务环节由于野生或非新食品原料品种河豚鱼偶入带来的潜在风险，提出政策建议，制定指导性意见和相应的安全监管措施。 本研究通过查阅了国内外相关文献资料，对当前河豚鱼从养殖到消费各环节开展了考察调研，发放调查问卷，召开监管部门、行业协会、科研专家、从业人员座谈讨论会，以及对加工人员开展培训，对养殖控毒河豚鱼和野生河豚鱼加工前后毒性的采样验证比较，确认管理办法中规定的识别措施、加工手段能否有效防止野生河豚鱼的流入，能否有效降低河豚毒素的毒性。 通过调查研究发现，目前公告中的两个品种养殖河豚鱼可以做到安全食用，但是野生或其它公告以外的品种还存在一定的安全隐患，须采取有效措施加强监管。据此，本次研究提出了对河豚鱼的监管必须是全链条的闭环监管模式，对河豚鱼养殖、生产经营单位实行资质认定制度，以原产地证明贯穿各环节，落实好索证索票和人员管理制度，按照加工操作规范进行操作。并制订了《养殖河豚鱼管理办法》、《养殖河豚鱼安全加工操作规范》、《养殖河豚鱼从业人员培训管理办法》和《餐饮服务单位经营养殖河豚鱼许可审查规范》等一系列规范要求保证河豚鱼食用安全。

Puffer fish has been consumed as gem of the fish for thousands of years in China. However, it contains Tetrodotoxin (TTX), which is a kind of highly poisonous alkaloid and its toxicity is 1,250 times than editpotassium cyanide. Improper processing or taken internally could result in toxication, even death. So there are a bunch of people “brave enough” to be “poisonous blowfish eaters” in China. Even though, it’s always forbidden of having puffer fish in China. Over the years, as the aqua cultivated toxicity control technology’s development, toxicity in cultivated puffer fish can be limited in safe level or even non-toxic. Recently, National Health and Family Planning Commission has passed the safety evaluation and requested public comments on breeding Fugu rubripes （Takifugu rubripes）and Takifugu obscurus as novel food material. has It can be expected that, once the cultivated puffer fish is approved to be as food, the domestic consumption market will be definitely stimulated . Nevertheless, some wild puffer fish or the other species beyond the approval would also be put on the tables, which is a potential risk to having puffer fish. Both the puffer fish dealers and consumers don''t have the capability to distinguish the wild toxic puffer fish against the cultivated ones, and some catering places are not qualified, especially we don’t have the related regulations, all these facts bring huge risk to the consumers. This thesis aims to give regulative recommendations and supervision measures against the possible food safety problem with the approval of the cultivated puffer fish and the potential risks, such as inadequate regulation system and standard system, deficient manufacture procedure, and interfusion of mild or non-food puffer fish during circulation and food service. To complete the study, this thesis has retrieved the relevant literature both at home and abroad in recent years. By sending questionnaire which covers the current chain of puffer fish from cultivation to consumption; and calling a meeting with the inspection authorities, industry association, research experts and workers in catering trade to discuss this topic. Besides, by carrying out relevant training to practitioners and conducting lab testing to compare the toxicity of the cultivated puffer fish and the wild ones before and after the processing to confirm whether the measures defined by the regulation effectively to lower the toxicity of Tetrodotoxin. . Investigation results show the two species puffer fish listed in the bulletin can be consumed safely, but the wild ones or the species other than the listed ones are not safe and required for effective measures to strengthen supervision. Therefore, this study suggests that government should establish the closed-loop supervision in the whole chains of Puffer fish, including cultivation, setting up systems to evaluating the qualification of production and business units. Not only the certificates of origin should throughout all links, but also asking for certification and invoice, as well as staff management system which in accordance with good manufacture procedure (GMP) should be practicable. . A series of regulations have been prepared to ensure the safe consumption of puffer fish, such as Regulation on the Cultivation of Puffer Fish, Safe Processing Manual of the Cultivated Puffer Fish, Regulation on the Personnel Training of Cultivation Puffer Fish, and Certification Review on the Catering Units in Dealing with the Cultivated Puffer Fish.