STC Number - 328

US default MRLs, limits of determination or limits of quantification on basmati rice

Maintained by: United States of America
Raised by: India
Supported by: New Zealand
First date raised: October 2011 G/SPS/R/64 para. 47-48
Dates subsequently raised: March 2012 (G/SPS/R/66 paras. 47-49)
July 2012 (G/SPS/R/67 paras. 29-30)
Number of times subsequently raised: 2
Relevant documents: Raised orally
Products covered: 1006 Rice.
Primary subject keyword: Food safety
Keywords: Food safety; Human health; Maximum residue limits (MRLs); Pesticides
Status: Resolved
Solution:
Date reported as resolved: 15/10/2014

Extracts from SPS Committee meeting summary reports

In October 2011, India stated that in August 2011, the US Food and Drug Administration (FDA) issued an import alert because of the presence of the fungicide Tricyclazole in a shipment of basmati rice. The shipment was detained without informing either the Indian Government or the exporter, and all subsequent consignments of basmati rice by that exporter were detained without physical examination. The US tolerance was at the Limit of Quantification, and consignments were being rejected for Tricyclazole residues exceeding 0.01 ppm. These detentions and the imposition of testing charges had resulted in huge losses to the exporter. Tricyclazole was a fungicide used for treatment of Blast in rice. The US tolerance limits conflicted with Article 5.4 of the SPS Agreement, which required Members to take into account the objective of minimizing negative trade effects, as Tricyclazole was widely used in India, China, Japan and Thailand for treatment of Blast. Further, Article 5.5 was not respected as the FDA permitted MRLs of Tricyclazole in rice bran, rice hulls and rice polishings of up to 30 ppm. No risk assessment, as mandated by Articles 2.2 and 5.1, seems to have been undertaken while setting the tolerance limit for Tricyclazole. India argued that the practice of setting default limits was contrary to the core principles of the SPS Agreement as there appeared to be no scientific justification, and it seemed to be contrary to the principle of harmonization of Article 3.

The United States replied that under the US Food, Drug, and Cosmetic Act, a food was deemed adulterated if it contained a pesticide for which there was no Environmental Protection Agency (EPA)-established tolerance or exemption, and food that is adulterated is not admitted into the United States. Several firms and products had been added to FDA's Import Alert #99-08, "Detention Without Physical Examination of Processed Foods due to Illegal Pesticide Residues" Products, including persimmon and rice flour, as well as basmati rice from three countries, had been subject to an Import Alert due to detection of Tricyclazole. The Government of India and the exporter were notified about the detention. When a shipment was detained, the importer had the opportunity to demonstrate that the shipment did not contain the residue, and FDA usually accepted private laboratory analysis as evidence that there were no residues. No tolerances for the use of Tricyclazole as a pesticide in rice had been established by EPA. The EPA had established tolerances for rice for three alternative fungicides, namely Azoxystrobin, Propiconazole, and Trifloxystrobin. India could use one of the alternative fungicides to combat rice Blast or work with EPA to establish a tolerance for Tricyclazole in the United States. The Codex had not established a maximum tolerance level for Tricyclazole in any food. The United States encouraged India to work with EPA and FDA to address the concerns.

In March 2012, India stated that in September 2011, Indian consignments of basmati rice were stalled at US ports for presence of the fungicide Tricyclazole in excess of the prescribed limit. The US tolerance was at the Limit of Quantification, and consignments were being rejected for Tricyclazole residues exceeding 0.01 ppm. India recalled that at the SPS Committee meeting in October 2011, the US authorities had provided a response indicating the lack of tolerances by the US Environment Protection Agency (EPA) for Tricyclazole in rice, and had noted that Codex had not established a maximum residue level (MRL) for Tricyclazole in any food. The United States had further reported that tolerances for rice had been established for three alternative fungicides and encouraged India to use one of those alternatives or work with the EPA to establish a tolerance for Tricyclazole. India argued, however, that under Article 5.1 of the SPS Agreement scientific justification should be provided for fixing any MRL for pesticides and that a Limit of Detection requirement must be justified. Tricyclazole was registered and used in the European Union, China and Japan for rice, with MRLs of 1 ppm, 2 ppm and 3 ppm, respectively. According to Article 5.7, Members could adopt the standards of other countries when there was no relevant international standard.India urged the Committee to invite the Codex Alimentarius Commission to examine the scientific basis of the US measure, under Article 12.6. US authorities had agreed to bilateral discussions and India urged the United States to allow imports based on the domestic standard of the exporting country, until both countries were able to finalize the MRL based on scientific justification.

The United States replied that under the US Food, Drug and Cosmetic Act, a food was deemed adulterated if it contained a pesticide for which there was no Environmental Protection Agency (EPA)-established tolerance or exemption, and food that was adulterated would be refused
admission into the United States. Several firms and products had been added to Food and Drug Administration's (FDA) Import Alert #99-08, "Detention without Physical Examination of Processed Foods due to Illegal Pesticide Residues", after FDA found residues of Tricyclazole and other pesticides at unapproved levels in shipments of basmati rice. When a shipment was detained, the importer had the opportunity to demonstrate that the individual shipment did not contain the residue, and the FDA usually accepted private laboratory analysis as evidence that there were no residues. To date, multiple shipments had been released in cases where approved laboratory findings demonstrated compliance with US tolerances, and one firm had been removed from Import Alert. Since the last Committee meeting, more chemicals without US tolerances had been detected in Indian basmati rice shipments into the United States. This raised fundamental concerns as to whether good agricultural practices were in place, rather than indiscriminate use of pesticides. One of the manufacturers of Tricyclazole had submitted a petition to the EPA in February 2011 to establish an import tolerance on basmati rice. The United States encouraged India to continue working with FDA and EPA to address the concerns of the Import Alert, and the presence of Tricyclazole and other pesticides.

India reiterated its request under Article 12.6 for the Committee to invite the Codex Alimentarius Commission to consider the scientific basis of the US measure, since no standards currently existed in relation to the issue. The Chair stated that India's request under Article 12.6 would require separate consideration and reminded India that the Committee would need to take a decision by consensus on this issue. The Chair invited India to submit its request in writing, for consideration by the Committee at the next regular session. New Zealand asked that India give a detailed account of the background of this issue in its request under Article 12.6.

In July 2012, India recalled that at the March SPS Committee meeting the United States had indicated that food was deemed adulterated if it was found to contain a pesticide for which there was no US established tolerance or exemption. In light of Articles 2.2 and 5.1 of the SPS Agreement, India requested the United States to provide the scientific justification for its MRLs for pesticides. Additionally, the United States should provide a scientific justification for establishing MRLs for pesticides at the limits of determination (LoD). India was working with the US Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) to address its concerns on the import alert, which had been issued due to the presence of tricyclazole and other pesticides. In this regard a letter had been set by Dow Chemicals to the US authorities providing details for fixing MRLs for tricyclazole at LoD. India urged the United States to expedite the process.

The United States reiterated that repeated violations of US law could result in putting a firm on an import alert, subjecting that firm to detention without physical examination. Since the initial detection of Tricyclazole in June 2011, the FDA had added 11 Indian firms to its import alert list, and a further seven pesticides were detected at unapproved levels. Since October 2011, the FDA had collected 70 samples of basmati rice from India, detecting pesticide residues of illegal substances in 36 shipments. Shipments that were able to demonstrate that they met US requirements were released into the US market, otherwise entry was refused. FDA was working with the Export Inspection Council in India to establish a voluntary compliance programme to monitor basmati rice shipped to the United States and ensure it was free of the pesticide. The All India Rice Export Association had also reported the initiation of outreach efforts on good agricultural practices to limit the use of illegal pesticides and chemicals in an effort to improve farming practices. The United States reiterated that the detention of shipments of basmati rice was due to the use of unapproved pesticides and encouraged India to inform exporters about the US tolerance regulations; to address the concerns of the US import alert; and to work closely with the FDA and the Export Inspection Council to resolve this public health concern.