Japanís export of raw intact beef to United States has more issues now than two years ago


By Dan Flynn, Food Safety News by Marler Clark

July 29, 2020


Japanís export of raw intact beef to the United States came in for review earlier this year in the form of an on-site equivalence verification audit by USDAís Food Safety and Inspection Service. FSIS auditors visited Japan from Jan. 27 to Feb. 14.


The audit report was released on July 24 to Akira MIKI, Food Safety and Inspection Division director for Japanís Department of Food Safety, Pharmaceutical and Food Safety Bureau. It is a unit of the† Ministry of Health, Labor and Welfare (MHLW).


The audit report follows an exit meeting in Tokyo on Feb. 1 at which FSIS presented preliminary findings to MHLW officials. In that meeting, the FSIS raised more issues with Japan that it did two years ago.


The FSIS auditors identified the following findings:


         The MHLW does not provide adequate oversight over the implementation of inspection tasks and microbiological procedures used for testing official samples;

         The eight MICsí microbiological laboratories are not meeting the quality assurance and control criteria established by the MHLW. Examples include:

o   Analyses for Salmonella do not include positive and negative control samples in biochemical confirmation.

o   Analyses for Shiga toxin-producing Escherichia coli (STEC) do not include positive and† negative controls in screening or confirmation methods.

         At seven establishments, the FSIS auditors observed the MIC inspectors peeling off the hide of cattle head to expose the masseter muscle and not incising deeply as required by the MHLW to inspect for cysticercosis.

         At five establishments, the MHLW does not ensure adequate oversight over the implementation of HACCP recordkeeping and verification requirements. Official records of ongoing verification of critical control points were not maintained or were incorrectly recorded.

         The MHLW does not have an adequate chain of custody system for laboratory operations. Most residue samples did not have signed security-seals and were not accompanied by transfer-and-storage records.

         The eight MIC laboratories are not analyzing the entirety of the N60 sample for Escherichia coli (E. coli) O157: H7 and non-O157 Shiga toxin-producing E. coli (STEC) during the screening of official testing;

         The MHLW has not implemented an appropriate method for STEC confirmation that meets equivalence expectations. The confirmation method does not include appropriate immune- concentration procedures with dilution or acid wash step to allow for adequate isolation of potentially low levels of STEC in a sample;

         At seven establishments, the collection of 60 pieces of beef trimming for STEC testing is performed by establishmentís personnel, not by MIC inspection personnel; and

         At seven establishments, the 60 pieces are neither trimmed from the exterior surface of carcass portions nor selected randomly.


During the audit exit meeting, the MHLW committed to addressing the preliminary findings as presented. The FSIS will evaluate the adequacy of the MHLWís documentation of proposed corrective actions and base future equivalence verification activities on the information provided...