The number of notifications was at least 18 last year, 13 in 2016, 28 in 2015, 14 in 2014 and five in 2013, based on import controls or operators' own-checks and official market controls.
Six notifications of aflatoxins in pistachios from the US have been reported this year in the RASFF portal.
The Directorate-General for Health and Food Safety audit took place from 5-12 September 2017.
The team visited three large processors-exporters and three orchards in California, two USDA approved labs and customs at Port of Oakland.
Official controls on pistachios exported to Europe
The previous audit concerning aflatoxin in pistachios in 2010 contained four recommendations which American authorities committed to addressing.
However, the most recent audit found there is no official control on pistachios exported to the EU.
“For the final products intended for human consumption in the US market, the sampling follows the procedure set out in the FMO [Federal Marketing Order] (lot sizes, sampling methods, testing and certification modalities) and is overseen by the local competent authority,” said the report.
“When the shipment is intended for export, there is no mandatory testing and no official control. It is up to the operator to decide whether the consignment is tested and the sampling procedure applied.
“Given the practices of mixing the deliveries of many producers in large silos, combined with the occasional use of pistachios from different silos or crop years in the assembly of a shipment exported to the EU, the traceability system does not allow to accurately identify the growers of origin.”
Creation of program to comply with EU requirements
The Administrative Committee for Pistachios (ACP) in the US is to create a voluntary program for aflatoxin certification concerning exports to the EU.
It will include a review of the almond aflatoxin testing program which could be used as a model.
ACP will also develop a procedure that ensures root-cause investigations and responses to the European Commission on each RASFF notification.
Establishing and documenting sampling procedures that meet European Commission requirements will be part of the program.
USDA said it will publish a proposed rule for public comment on the subject.
In 2016, the US commerce department reported the volume of exports to the EU was 44,054 tonnes of pistachios (including 37,400 tonnes in-shell).
Pistachios, in shell or shelled, from the US are subject to a minimum inspection rate of 10%.
The US action limit for total aflatoxins is 20 μg/kg but there is no separate limit for aflatoxin B1.
Regulation (EC) No 1881/2006 set the maximum limit for pistachios imported into the EU at 10 μg/kg for total aflatoxins intended for direct human consumption and 8 μg/kg for aflatoxin B1.
Lack of investigation after RASFF alerts
Import controls of pistachios returned from the EU after rejection are subject to the special crops import regulation which sets total aflatoxins contamination limit at 15 μg/kg.
The audit found in cases where consignments of pistachios from the US are rejected by EU Member States due to aflatoxin, resulting notifications to US authorities under RASFF are not adequately followed up to investigate root causes or to implement preventive measures.
The large majority of pistachios exported to the EU are grown and processed in California. Small quantities also come from Arizona and New Mexico.
Sorting is considered a critical step to reduce aflatoxin contamination in the final product by removing nuts presenting insects damages, abnormal staining, discoloration or moulds.
The audit team said it observed measures by the sector to prevent aflatoxin contamination in pistachios for export to the EU.
“Many developments in the management of orchards and in the methods of preventing contamination of pistachios by aflatoxin-producing fungi are carried out by growers. Processors apply pertinent good manufacturing practices and aflatoxin risk management and treatments.
“Shipments of exported pistachios are generally subject to voluntary aflatoxin analyses carried out in US Department of Agriculture (USDA) approved laboratories.”
Sampling equivalence issues
Sampling forms sent to labs contain identification of the operator, the analyses requested, lot number and size and market of destination.
“There is however no information related to the sampling procedures applied, the number and weight of incrementals taken or whether the aggregate sample was correctly mixed. There is also no information on the intended use (human consumption or intended for further processing),” said the report.
“Representativity of samples for aflatoxin testing is not ensured which can compromise the reliability of analytical results used for the validation of batches of pistachios exported to Europe.”
Analytical reports reviewed by the audit team did not always state limit of detection or quantification, the measurement of uncertainty and/or whether results are expressed on a recovery corrected basis or not as required by Regulation (EC) No 401/2006.
“When analyses are carried out on batches of pistachios exported to the EU, the analysis and reporting procedures are not at least equivalent to [the regulation] to ensure control labs use methods of analysis with comparable levels of performance for the official control of the levels of aflatoxin in pistachios. The compliance of pistachios exported to the EU with the limits for aflatoxin contamination set by Regulation (EC) No 1881/2006 cannot be guaranteed.”
USDA added analysis and reporting procedures have been revised to include LOQ, measurement uncertainty value for all results or those greater than 2 ug/kg and corrected for recovery result for all results or those with spike recoveries not within the range of 90–100% or greater than 2 ug/kg on the analytical report.
Each lab currently in the program will need to verify method validation contains each element and where needed update validation and each new lab will provide its method validation and meet requirements before acceptance.