Japan’s 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 USDA’s 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 Japan’s 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 MICs’ 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 establishment’s 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 MHLW’s documentation of proposed corrective actions and base future equivalence verification activities on the information provided.

As a result of the audit, FSIS also found that Japan’s  MHLW has not fully met the requirements of the Shiga toxin-producing E. coli (STEC). E. coli O157:H7 verification program because of improper collection procedure of N60 samples, not implementing an appropriately validated STEC confirmation method, and not using all the N60 sample for official testing purposes at certified establishments to ensure that raw beef products are free of STEC at the end of the production process.

FSIS import inspectors re-inspected 100 percent of the raw intact beef exported by Japan to the United States from Sept. 1, 2016, to Aug.31, 2019. The re-inspections totaled  almost 2.5 million pounds of raw intact beef. Of this amount, additional types of inspection were performed on 190,613 pounds of raw intact beef, including examination, chemical residue analysis, and testing for microbiological pathogens (Shiga toxin-producing Escherichia coli (STEC) O157:H7, O26, O45, O103, O111, O121, and O145 in beef), and 1057 pounds of products were rejected for issues not related to public health. 

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