Japan protocol development

Since the MHLW designated shrimp/prawn and crab for mandatory labeling in June 2008 due to the almost unlimited use of crustacean in the processed foods in Japan and the status as a frequent cause of adverse food reactions in allergic patients, two ELISA methods for the determination of crustacean protein in processed foods have been developed (Seiki et al, 2007 Shibahara et al., 2007) EA test EIA-Crustacean [Nissui] produced by Nissui Pharmaceutical Co., Ltd. and Crustacean Kit [Maruha ] produced by Maruha Nichiro Eoods, Inc. Both kits have been validated according to the Japanese validation protocol (Sakai et al., 2008) and are commercially available. All the commercial ELISA kits are shown in Table 4.9. 

An important hardware addition in the development of fiber-spinning protocols is the availability of customized wet-spinning apparatus from Nakamura Services Co. in Japan (Figure 7.9). 

Endo and co-workers at Ehime University, Matsuyama, Japan, have led the development of the most promising eukaryotic cell-free system to date, based on wheat embryos. A significant advance made by this group was the development of pEU expression vectors that have overcome many of the difficulties associated with mRNA synthesis for translation in a eukaryotic system [8]. In addition to extensive optimization of reaction conditions that have seen improvements in protein synthesis rates, Endo and colleagues have improved wheat extract embryo preparation protocols to enhance the stability of these systems to a remarkable extent [9]. When coupled with the dialysis mode of reaction, Endo et al. were able to maintain translational activity in a coupled transcription/ translation wheat embryo reaction for 150 hours, producing 5 mg of enzymatically active protein per mb reaction mixture [10]. This again represents a serious alternative to in vivo methods of large-scale protein production. 

The easy availability of substitutes is a factor that permitted compliance to the Protocol. Science and industry have been able to develop and commercialize alternatives to the CFCs and other ozone-depleting compounds. In fact, industrialized countries like Japan and Singapore ended their dependence on CFCs at less cost than was anticipated. 

The scarcity of purified ciguatoxin standards and the challenging nature of analyses for ciguatoxins in fish tissues precluded development or adoption of ciguatoxin methods in most laboratories. While many are certainly capable, only a few laboratories have produced the necessary standards and sustained support required for development and routine application of screening assays and confirmatory analyses for ciguatera toxins. Protocols for in vitro assay and LC-MS/MS analysis of fish tissues have been developed in U.S. Food and Drug Administration (FDA) and National Oceanic and Atmospheric Administration (NOAA) laboratories. Laboratories in Japan (T. Yasumoto) and Australia (R. Lewis) use similar protocols that predate those in the United States. 

Several standard test protocols for measurement of polymer biodegradation are presently available. Organizations which have published such tests include the American Society for Testing and Materials (ASTM), Ministry of International Trade and Industry (MITI) (Japan) [40] and the Organization for Economic Cooperation and Development (OECD) [41]. They are, however, for the most part deficient to the extent that they have no control over the nature of microbial inoculum used, or the possible preadaptation of the mixed populations to specific substrates, and over the adequate control of particle size of the substrate. The relevance of these factors to laboratory assessment of the biodegradabUity of synthetic polymers has been recently discussed [1]. Most of these test methods have been derived from tests first used with detergents [42], and are not always well-suited for solid polymer substrates. 

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