Japan EV Program Verification Period Now Ended
June 13, 2007
On July 27, 2006, Government of Japan (GOJ) resumed imports of U.S. beef based on findings of the on-site review of all establishments certified as eligible to export to Japan.
Responsibility primarily rests with United States Government (USG) for compliance of U.S. beef with the export requirements for Japan. Both GOJ and USG, through various measures, have been conducting verification activities to assure compliance with the Japan Export Verification (EV) Program.
Based on findings of the audit conducted by GOJ May 13-28, 2007, in U.S. establishments certified by USDA to export to Japan, GOJ and USG reached a shared understanding about the compliance of U.S. establishments with U.S. food safety requirements and the Japan EV Program since July 27, 2006, as summarized below.
I. Measures taken by the United States
- Measures taken by Establishments
- All establishments certified as eligible to export to Japan have developed and maintain up-to-date lists of products approved for export to Japan.
- All establishments certified as eligible to export to Japan document and maintain sufficient descriptions of effective procedures for SRM removal and other Japan EV Program-related procedures.
- All establishments certified as eligible to export to Japan have thoroughly trained all relevant plant management and employees regarding Japan EV Program requirements.
- Measures taken by AMS/USDA
- Prior to USDA certification as eligible to export to Japan, AMS verified the appropriateness of establishments' manuals and the establishments' thorough understanding of their Japan EV Programs.
- AMS has maintained for each eligible establishment a list of products approved for export to Japan.
- In accordance with AMS procedures and ISO standards, AMS conducted bi-annual surveillance audits of the establishments with approved Japan EV Programs.
- AMS has conducted eight unannounced audits so far.
- Measures taken by FSIS/USDA
- FSIS has trained its inspectors in the Japan EV Program. To successfully complete the training, FSIS inspection program personnel had to pass an EV Program exam. Successful completion has been recorded for each employee in the FSIS training database.
- Prior to issuing export certificates, FSIS inspection personnel confirm that the inspected products offered for export are on the establishments' approved product lists.
- FSIS has conducted eight unannounced audits so far.
- General Summary
AMS has verified, through both announced and unannounced audits, that exporting establishments are accredited for export to Japan, maintain a list of eligible products for export to Japan, and have appropriate management of their Japan EV Programs. FSIS has provided effective instruction and training to inspectors regarding the issuance of export certificates to Japan, requiring inspectors to pass a test on the EV Program requirements. FSIS inspectors have confirmed the eligibility of establishments and products prior to the issuance of export certificates.
On four occasions, shipments were found to contain products which were inspected and passed as wholesome for human consumption in the United States but not intended for export to Japan. Following submission of investigative reports by the United States, the causes of these incidents have been recognized as isolated cases with effective corrective actions taken.
II. Measures Taken by Japan
- On-site review by GOJ on the U.S. establishments prior to resumption of shipment to Japan
- During June 24 - July 23, 2006, GOJ conducted an on-site review of the 35 U.S. establishments accredited to export to Japan.
- As a result of GOJ's on-site review for the 34 establishments that did not have any specific issues identified and that implemented corrective actions (includes one establishment conditionally certified), on July 27, 2006, USG put these establishments in the official listing of eligible suppliers for the Japan EV Program.
- For one establishment, which was in the process of a change in ownership due to a corporate merger, USG put the establishment in the official listing of eligible suppliers for the Japan EV Program on August 15, 2006, upon completion of the procedure and subsequent confirmation by GOJ.
- An audit by GOJ after the resumption of shipment to Japan and accompanying USDA's unannounced audit
- During November 26 - December 13, 2006, GOJ conducted an on-site audit, which involved eight U.S. establishments accredited for export to Japan (including auditing two of the establishments while accompanying USDA's unannounced audits). During May 13 - May 28, 2007, GOJ conducted another on-site audit involving 27 of the U.S. establishments accredited for export to Japan and one establishment scheduled to be newly accredited. There were no issues pointed out which could affect the Japan EV requirements.
- In the on-site audits mentioned in the above 1), no systemic problems were found with respect to the Japan EV Program. GOJ found that USG conducted investigations of the concerned establishments about the causes of each incident such as misloading of ineligible products and that those establishments implemented corrective measures as appropriate.
- GOJ has made the following requests to USG for prevention of incidents such as misloading of ineligible products in order to prevent future occurrence.
- Comparing with beef derived from carcass, handling of offal requires work to be done by hand such as packaging, segregation and labeling. Therefore, thorough verification of the shipping department should be conducted by establishments while AMS audit should also focus on the packaging, segregation, and control and labeling of offal products.
- When products, which require special handling and segregation procedures, are newly put on the eligible product list, AMS should verify, through its approval of the product list and audits, not only the documented procedures, but also if the required equipment is actually in place, which is necessary to process the products at the establishments, and that proper training has been provided to plant employees in the following instances: e.g., in an establishment that previously conducted age verification by the A-40 age verification method and changes to producing the products from age verified animals: or in an opposite case wherein an establishment that previously produced the products from age verified animals and changes to producing the products by using the A-40 age verification method.
- Border Inspection
- 100% box inspection conducted in cooperation with Japanese importers
For all boxes of U.S. beef at the time of import to Japan, verification was conducted to check whether or not SRMs were present and the actual products were consistent with the health certificate.
- Border inspections by the MHLW quarantine stations and MAFF animal quarantine stations
- MHLW quarantine stations, upon implementing all-lots inspection on U.S. beef, conducted verification to check whether or not SRMs were present and the actual products were consistent with the health certificate.
- In addition to checking the documentation with the product list of the establishments, MAFF quarantine stations conducted all-lots inspection on actual U.S. beef products to verify the presence of SRMs and their consistency with the health certificate.
- Import Records
By the end of May 2007, 19,000 MT of beef had been imported and undergone 100-percent box confirmation and subsequent inspection. During the above verification period, four incidents with the products not described in the health certificate were confirmed, including those reported by concerned parties, while no systemic problems were found with respect to the Japan EV Program.
- Misloading incident of sweetbread not on the product list at Swift Greeley plant (Press Release on November 8, 2006)
- Misloading incident of beef not having the age verification at Tyson Lexington plant (Press Release on February 16, 2007)
- Misloading incident of beef tongue not having the age verification at Cargill Dodge City plant (Press Release on April 6, 2007)
- Misloading incident of omasum (third stomach) at Cargill Fort Morgan plant (Press Release on May 21, 2007)
- Actions taken against the incidents of noncompliant product
- Based on the nature of the incidents, GOJ suspended import procedures for beef shipped from the establishments concerned at MHLW quarantine stations and MAFF animal quarantine stations.
- Based on USG's submission of the investigation reports, which identified the causes of the incidents and the corrective actions taken, and upon conducting an on-site audits and confirming that the incidents were appropriately addressed, GOJ resumed its import procedures from the concerned establishments above.
- Also, in response to these incidents, GOJ requested USG to instruct all U.S. establishments accredited for export to Japan to strengthen their check system at the shipping stage. In the audit conducted in May 2007, the above U.S. system check was verified.
- GOJ requested that USG de-list the establishments, which violated the Japan EV requirements, from the list of establishments certified as eligible to export to Japan. In response, USDA stopped issuing the export certificate since delisting applies when an establishment has violated the food safety requirements in the United States or when an establishment does not meet the certification requirements of the Japan EV Program.
- Guidance and thorough education for importers about Japan EV Program requirements
- GOJ held seminars concerning U.S. beef imports under the Japan EV Program, targeting Japanese importers on July 5 and August 2, 2006.
- MHLW quarantine stations promoted thorough education on the Japan EV Program for Japanese importers by holding seminars and distributing manuals for import procedures of U.S. beef and the necessary details to be followed in 100-percent box inspection and etc.
- MAFF Animal quarantine stations issued a notice to Japanese importers (dated July 27, 2006) about the basic criteria for its import inspection to promote thorough education on the Japan EV Program. They also conducted seminars on July 31 at 6 animal quarantine stations with air/sea ports under their jurisdiction expected to have imports of U.S. beef.
- General Summary
Based on findings of the on-site review conducted in June and July, 2006, GOJ resumed imports procedures of U.S. beef. After the resumption, no systemic problems related to compliance with the Japan EV Program were found through verification activities such as audits conducted on the establishments certified as eligible to export to Japan, including those with isolated incidents, import inspections at MHLW quarantine stations and MAFF animal quarantine stations, and 100-percent box inspection conducted in cooperation with Japanese importers. Also, regarding the misloading incidents of ineligible products that were found during the verification period, GOJ verified USG's investigation of the causes of the incidents and the corrective measures taken by the establishments, and found that the incidents were appropriately addressed.
III. Evaluation of the Verification Period
- GOJ and USG verified the U.S. compliance with the Japan EV Program, through measures taken mentioned in above I and II, and reached a shared understanding that the U.S. system is functioning.
- Also, with respect to four misloading incidents of ineligible products found in Japan's border inspection, it was determined by USDA's investigations that these incidents were all isolated cases. GOJ, through conducting on-site audits, verified the above.
- Given the above, USG ended the verification period and will start certifying new establishments.
- GOJ and USG will take the measures mentioned in IV in order to verify continued compliance with the U.S. food safety requirements and the compliance with the Japan EV Program.
- With respect to Tyson's Lexington plant and Cargill's Fort Morgan plant and Dodge City plant, GOJ will lift the suspension of import procedures.
IV. Measures to be Taken
- Measures to be taken by the United States
- USDA will maintain the necessary controls to ensure that establishments effectively comply with export programs for Japan, which are in place at the time of export. FSIS inspectors will continue to issue export certificates to Japan in accordance with FSIS inspection requirements and Japan import requirements.
- Upon notification to USDA of a shipment of ineligible product, USDA will determine the cause of the problem and take corrective actions as appropriate.
- USDA will notify GOJ, in a prompt manner, about the change in the listing of the establishments certified as eligible to export to Japan, which is posted in USDA's Web Site. USDA will coordinate with GOJ to conduct an annual audit of the U.S. meat inspection system and the Japan EV Program, which may include newly certified plants. Also, USG will continue conducting an unannounced audit in an appropriate manner.
- Measures to be taken by Japan
- Conducting Import Inspections
- MHLW quarantine stations and MAFF animal quarantine stations will continue verifying U.S. compliance with the Japan EV Program by conducting sampling inspections while taking into account export records to Japan and problems found in the past.
- GOJ will no longer conduct 100-percent box inspection by Japanese importers, which was originally implemented as a temporary measure, for establishments that, through the measures under II, have been verified by GOJ to have no problems, or have had problems but have been verified by USG as having completed the corrective measures; and for establishments certified in the future by USDA as eligible to export to Japan.
- Conducting Audits
GOJ will continue verifying compliance of U.S. beef products with the food safety requirements in the United States and the Japan EV Program requirements through an on-site audit as part of the verification of the equivalence of the U.S. meat inspection system.
- Guidance and thorough education for Japanese importers
GOJ will redouble its efforts in giving guidance to and thoroughly educating Japanese importers about the Japan EV Program. Also, GOJ will announce the name of the importer in case the problem is identified by border inspection at its quarantine stations based on Article 63 of the Food Sanitation Law.
- Responses When Problems Found
When imports of ineligible products are confirmed by Japan, GOJ will take appropriate measures commensurate with the nature of the problem based on USDA's investigation of the causes of the incidents and the corrective measures taken.
- Conducting Import Inspections
- 100% box inspection conducted in cooperation with Japanese importers