Global harmonization of food safety regulations: perspectives from Japan after the Fukushima nuclear accident.

Japanese food self-sufficiency was only 39% on the basis of kcal in 2012, so Japan relies heavily on imported food. Hence the necessity of having international rules on the regulation of food contaminants is important especially for countries like Japan that depend on food imports. A One-Stop-Testing system is desired, in which the test result obtained from a single testing laboratory is accepted as valid worldwide. To establish this system, laboratory accreditation under international standards is a necessary step. Furthermore, the importance of supply of reference materials for internal quality control and proficiency testing for external quality control of each laboratory's analytical system is reviewed in connection with the experience of radioactive nuclide contamination resulting from the Fukushima nuclear power plant accident in March 2011.

Safety regulations of food and water implemented in the first year following the Fukushima nuclear accident.

An earthquake and tsunami of historic proportions caused massive damage across the northeastern coast of Japan on the afternoon of 11 March 2011, and the release of radionuclides from the stricken reactors of the Fukushima nuclear power plant 1 was detected early on the next morning. High levels of radioiodines and radiocesiums were detected in the topsoil and plants on 15 March 2011, so sampling of food and water for monitoring surveys began on 16 March 2011. On 17 March 2011, provisional regulation values for radioiodine, radiocesiums, uranium, plutonium and other transuranic α emitters were set to regulate the safety of radioactively contaminated food and water. On 21 March 2011, the first restrictions on distribution and consumption of contaminated items were ordered. So far, tap water, raw milk, vegetables, mushrooms, fruit, nut, seaweeds, marine invertebrates, coastal fish, freshwater fish, beef, wild animal meat, brown rice, wheat, tea leaves and other foodstuffs had been contaminated above the provisional regulation values. The provisional regulation values for radioiodine were exceeded in samples taken from 16 March 2011 to 21 May 2011, and those for radiocesiums from 18 March 2011 to date. All restrictions were imposed within 318 days after the provisional regulation values were first exceeded for each item. This paper summarizes the policy for the execution of monitoring surveys and restrictions, and the outlines of the monitoring results of 220 411 samples and the enforced restrictions predicated on the information available as of 31 March 2012.

Food safety regulations: what we learned from the Fukushima nuclear accident.

On 11 March 2011, the magnitude-9.0 earthquake and a substantial tsunami struck off the northeast coast of Japan. The Fukushima nuclear power plants were inundated and stricken, followed by radionuclide releases outside the crippled reactors. Provisional regulation values for radioactivity in food and drink were set on 17 March and were adopted from the preset index values, except that for radioiodines in water and milk ingested by infants. For radiocesiums, uranium, plutonium and transuranic α emitters, index values were defined in all food and drink not to exceed a committed effective dose of 5 mSv/year. Index values for radioiodines were defined not to exceed a committed equivalent dose to the thyroid of 50 mSv/year, and set in water, milk and some vegetables, but not in other foodstuffs. Index values were calculated as radioactive concentrations of indicator radionuclides ((131)I for radioiodines, (134)Cs and (137)Cs for radiocesiums) by postulating the relative radioactive concentration of coexisting radionuclides (e.g., (132)I, (133)I, (134)I, (135)I and (132)Te for (131)I). Surveys were thence conducted to monitor levels of (131)I, (134)Cs and (137)Cs. Provisional regulation values were exceeded in tap water, raw milk and some vegetables, and restrictions on distribution and consumption began on 21 March. Fish contaminated with radioiodines at levels of concern were then detected, so that the provisional regulation value for radioiodines in seafood adopted from that in vegetables were additionally set on 5 April. Overall, restrictions started within 25 days after the first excess in each food or drink item, and maximum levels were detected in leafy vegetables (54,100 Bq/kg for (131)I, and a total of 82,000 Bq/kg for (134)Cs and (137)Cs). This paper focuses on the logic behind such food safety regulations, and discusses its underlying issues. The outlines of the food monitoring results for 24,685 samples and the enforced restrictions will also be described.

Food after Fukushima--Japan's regulatory response to the radioactive contamination of its food chain.

The nuclear accident in Fukushima triggered a process of regulatory action, inspections, and market restrictions that has deeply affected the Japanese food market. When higher than permissible levels of radioactivity entered the food chain, the Japanese Government had to take strong measures to protect consumers. At the same time, it had to explore ways to avoid disproportionate penalties on the producers from the affected region. This article examines Japan's regulatory response to the nuclear accident and the legal instruments the government accordingly employed. Our analysis follows four regulatory steps that were taken by the government to safeguard the food chain: the establishment of maximum permissible levels for radioactive levels in food; the adoption of guidelines on how to monitor these levels; the restriction of the distribution and consumption of excessively contaminated food and, finally, where and when possible, the lifting of these restrictions. This article discusses how the Food and Drug Administration has come to adopt informal guidance (agency advice that influences regulated entities but does not carry the force and effect of law) as its primary method of policymaking, as opposed to more formalized procedures like notice-and-comment rulemaking or case-specific adjudication. Using major developments in administrative law and modifications to FDA's regulatory regime as milestones, the article traces how and why FDA's use of informal guidance to fulfill its statutory mandate has changed over the past century. Along the way, the article identifies important doctrinal questions that persist today, namely (1) whether informal advisory opinions bind FDA and (2) the degree of judicial deference guidance documents should receive under the Supreme Court's decisions in Chevron and Mead. The article attempts to resolve these doctrinal ambiguities. It then undertakes a normative analysis of FDA's increasing reliance on informal guidance, and conclude that, on the whole, this development has benefited FDA's major stakeholders: regulated entities, the general public and the agency itself. The article closes with modest proposals for reform. The article features an appendix with several tables illustrating FDA's output of informal guidance documents by year, to facilitate further study.

Nuclear energy in postwar Japan and anti-nuclear movements in the 1950s.

The atomic bombings of Hiroshima and Nagasaki in August 1945 revealed the most destructive power to-date of man-made weapons. Their impact was so great that Japanese scientists thought that a bigger disaster could be prevented only if war was abolished. Thus they welcomed the international control of atomic energy. It was, however, only after the occupation that the Japanese general public began to learn about the horror of these atomic disasters due to the censorship imposed by the occupational forces. The hydrogen bomb test by the US in the Bikini atoll on March 1, 1954 renewed fears of nuclear weapons. The crew of a Japanese fishing vessel, the "Daigo Fukuryu Maru" (Lucky Dragon No. 5) suffered from exposure to radiation from the test. Even after the incident the US did not stop nuclear tests which continued to radioactively contaminate fish and rains in Japan. As a result, the petition movement for the ban of nuclear trials suddenly spread all over the country. By the summer of 1955 the number of the signatures grew to more than one third of Japan's population at the time. Under the strong influence of anti-nuclear Japanese public opinion the Science Council of Japan announced the so-called three principles of atomic energy: "openness," "democracy," and "independence" to ensure atomic energy was used for peaceful uses only. These principles were included in the Atomic Energy Basic Law established in December 1955. With this law, military uses of nuclear energy were strictly forbidden.

Regulations for radioisotope content in food- and feedstuffs.

The regulation of contamination levels in food and feed should be made in connection to each other, and described here is a guideline level system with decision rules for radionuclide content in foodstuffs and feedstuffs. Levels for foodstuffs are derived from the general dose limits established by the International Committee of Radiological Protection. For foodstuffs, two levels are suggested: tolerance level for normal situations based on 0.1 mSv/year ingestion dose, and acceptance level for prolonged emergency situations based on 1 mSv/year committed effective dose, with the application of a protection factor of 5 and 3, for children younger than one year and adults, respectively. Current legislation does not contain any derived limits for normal everyday use; however, it is necessary to incorporate limits soon, not only because of the wide use of nuclear technology but also the threat of violent events where foodstuffs are as a vehicle. In addition, technologically enhanced natural isotopes can also cause problems. The derivation of the acceptance level in feedstuffs is based on the suggested acceptance level in foodstuffs, in addition to the latest literature review of transfer coefficients performed in the frame of the Environmental Modelling for Radiation Safety program of the International Atomic Energy Authority.

Perceptions of risk, dilemmas of policy: nuclear fallout in Swedish Lapland.

This paper concerns risk perceptions of Swedish Saami reindeer herders in conjunction with the Chernobyl nuclear disaster. Focus is also placed upon their experiences of damage and their efforts to deal with these problems. Data relating to these social aspects of the Chernobyl event come from interviews with members of Saami herding families. The initial governmental policy of establishing a simple contamination limit for the marketability of all foodstuffs was beset with shortcomings. I propose that all contaminated foods should be labeled with contamination specifications along a fully graded scale. In addition, there should be consumer education and recommendations for the entire population, not just one segment. An absolutely necessary step in the construction of valid policies is the health calibration of low-dose radiation. Without such knowledge, any marketability limit is suspect. With such knowledge, policy can be firmly based on human health.