STC Number - 267

Pesticide maximum residue level (MRL) enforcement system

Maintained by: Japan
Raised by: China; United States of America
Supported by: Ecuador; New Zealand
First date raised: June 2008 G/SPS/R/51, paras. 15-17. See also STC 212 and STC 283
Dates subsequently raised: October 2008 (G/SPS/R/53, paras. 15-18)
February 2009 (G/SPS/R/54, paras. 33-34)
October 2009 (G/SPS/R/56, paras. 50-52)
March 2010 (G/SPS/R/58, paras. 31-32)
June 2010 (G/SPS/R/59, paras. 37-38)
Number of times subsequently raised: 5
Relevant documents: Raised orally
Products covered: 02 Meat and edible meat offal; 04 Dairy produce; birds' eggs; natural honey; edible products of animal origin, not elsewhere specified or included; 07 Edible vegetables and certain roots and tubers; 08 Edible fruit and nuts; peel of citrus fruit or melons; 09 Coffee, tea, mate and spices; 10 Cereals; 12 Oil seeds and oleaginous fruits; miscellaneous grains, seeds and fruit; industrial or medicinal plants; straw and fodder
Primary subject keyword: Food safety
Keywords: Control, Inspection and Approval Procedures; Food safety; Human health
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In June 2008, the United States noted that in May 2006, Japan's Ministry of Health, Labour and Welfare (MHLW) imposed a testing and sanctions policy that involved increased testing (30 per cent country-wide) after the occurrence of one MRL violation. If a second violation involving the same pesticide and commodity occurred within one year of the first, a 100 per cent test-and-hold policy was enforced on all exports of that commodity from that country. The United States believed that the sanctions under inspection and control programmes should be limited to the violating supplier as long as there was no indication that a country-wide problem existed. The United States considered that this would be the least trade restrictive measure and the most appropriate policy. This was also the policy applied by the United States itself.
China supported the concerns raised by the United States and invited Japan to provide scientific justification for its measure, in order to comply with the SPS Agreement.
Japan stated that the MRLs for agricultural chemicals in food were developed based on scientific assessments, and took into account the MRLs established by Codex and by other countries. Before adopting a new MRL, Japan notified its proposal to the WTO and considered any comments from Members, as appropriate. The MRLs applied equally to domestic and imported products. Whenever non-compliance with an MRL was found in imported products, Japan strengthened inspections of agricultural chemical residues. The degree, frequency, or extent of enhanced inspection was determined by the circumstances. Each violation was handled on a case-by-case basis, but always conducted in a rational and reasonable manner, for instance, by limiting the enhanced inspections to the violating exporter only.
In October 2008, the United States again raised its concerns about Japan's enforcement system for MRLs. In particular, there was no reason for Japan to employ country-wide sanctions where there was no indication of a country-wide problem. In cases of individual company violations, sanctions should be applied at the individual company level.
New Zealand noted that its exports had been subject to testing by Japan. New Zealand asked for further clarification regarding the reasons behind testing products, especially asparagus products as these were normally frozen.
China shared the US concerns regarding Japan's testing regime.
Japan responded that in order to enforce their MRLs, Japan conducted monitoring inspections of agricultural chemical residues in imported food. These controls were strengthened if imported products did not comply with the established MRLs. Multiple violations had been detected on imported products from the United States, giving rise to increased monitoring.
In February 2009, the United States indicated that Japan's MRL enforcement policy imposed on US specialty products continued to be of great concern. This policy imposed industry wide testing for pesticides after one MRL violation by a single party. If a second violation involving the same pesticide and commodity occurred within one year, a 100 per cent test-and-hold policy of all exports from that country was enforced.
Japan indicated that the MRLs had been developed based on scientific assessments, taking into account Codex standards, and that they were applied both to domestic and imported products. When there were instances of non-compliance, inspections were strengthened, taking into account various factors, on a case-by-case basis. Japan had confirmed that the US regulation on pesticide residues was equivalent to Japan's. Where US MRLs were equal to or stricter than Japan's, the enhanced inspections were limited to the specific exporter. In cases where the US MRL was higher than Japan's, Japan needed to ensure that US exporters as a whole complied with Japan's MRL. Such evidence should be provided by the US Government itself, or in some other way. In fact, Japan's inspection records showed that multiple violations had been detected by the enhanced inspections after an initial violation. This suggested that responsibility of the exporter alone did not always ensure compliance with Japan's MRLs. Japan needed a mechanism to ensure that exporters complied with Japan's MRLs, e.g. a compliance programme established by industry or information on their compliance history. If the United States provided such information, it would enable Japan to consider limiting the enhanced inspection to the specific exporter. Japan hoped to continue technical discussions with the United States.
In October 2009, China recalled that after the implementation of Japan's positive list system for chemical residues, China and many other WTO Members had expressed concerns regarding the issue of "uniform standards". Japan had indicated that the standard would be revised on the basis of scientific evaluations and MRLs would be established for more chemical residues. In recent years, almost all notices that China received from Japan regarding products that exceeded pesticide limits were caused by the "uniform standards". These had severely affected China's trade with Japan. Also, after the implementation of Japan's positive list system, a series of regulatory measures such as intensified inspection, quarantine and supervision, had been undertaken. China urged Japan to develop science-based residue limits for the items of concern as soon as possible, to alleviate unnecessary restrictions to international trade.
Ecuador supported China's concern regarding MRLs applied by Japan. Ecuador's cocoa exports had faced difficulties of market access, and although various meetings had taken place, no solution had been provided. Ecuador requested Japan to modify its MRLs in accordance with international standards.
Japan stated that the uniform standard was based on the evaluations by the FAO/WHO Joint Expert Committee on Food Additives (JECFA) and/or on the tolerance exposure amounts that the US Food and Drug Administration adopted for food additives.

In March 2010, China reiterated the concerns regarding Japan's MRLs and its enforcement system, which should be based on scientific evidence and applied in a least-trade restrictive manner. According to China, out of approximately 50 thousand MRLs in Japan, more than 40 thousand were "temporary" standards, which were neither based on scientific evidence nor risk assessments as required by the SPS Agreement. Less than 50 per cent of the "temporary" standards had been reviewed by the end of 2009, although they had been applied for almost five years, creating serious obstacles to China's food exports to Japan. Moreover, Japan's "uniform standard" of 0.01 ppm MRL for several products was not based on scientific evidence. MRLs should be set according to the different levels of exposure through different food products, toxicology evaluations and acceptable daily intake (ADI) levels consistently with international practice. In addition, Japan's enforcement system of MRLs was neither reasonable nor transparent, as sometimes Japan inspected 100 per cent of China's food exports, known as "order inspections". By way of examples, Japan set a 2 ppm MRL for pyrimethanil in scallion, while for shallots Japan applied the "uniform standard" of 0.01 ppm. Japan also applied the 0.01 ppm "uniform standard" for chlorpyrifos in matsutake, while the Codex standard for chlorpyrifos in edible fungi was 0.05 ppm. China also asserted that Japan applied a less favourable treatment to imported food products than to Japanese products.
Japan responded that the "uniform limits" had been established after holding consultations and receiving opinions from health experts based on: (i) acceptable exposure levels determined by the evaluations conducted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and evaluations on indirect additives by the United States Department of Agriculture (USDA); (ii) acceptable dairy intake for pesticides and veterinary drugs evaluated by JECFA; and (iii) the default level of 0.01 ppm established by the European Union. According to the Japanese system, the Ministry of Health, Labour and Welfare conducted an evaluation before allowing pesticide residues in food products. This evaluation was based on individual pesticide residue data for each commodity. Any exporter could apply to the Ministry of Health, Labour, and Welfare to request the evaluation of specific data on MRLs.

In June 2010, China reiterated its concerns regarding Japan's MRLs and their enforcement system. China welcomed the SPS cooperation arrangement recently signed between Japan and China and the first round of technical consultations which had taken place under the new arrangement. Nevertheless, China wished to reiterate its concerns regarding the temporary standards under Japan's Positive List scheme, the lack of scientific basis for those standards, and a lagging review process.
Japan responded that its Positive List system had been established in 2006 after consulting existing MRLs from Codex, Australia, Canada, New Zealand, the European Union and the United States, based on a scientific evaluation. Japan stated that its standard-setting process was in line with the SPS Agreement, and that it had notified its draft MRLs to the WTO, providing Members an opportunity to submit comments.