Jensen Farms auditor did not follow FDA processing guidance

By Mark Astley

- Last updated on GMT

PIC copyright: United States Government Work
PIC copyright: United States Government Work
Auditors who gave Jensen Farms a “superior” rating, only months before a lethal Listeria outbreak, largely ignored FDA antimicrobial guidance, a US government report has found.

In 2010 and 2011, Bio Food Safety, which had been subcontracted by Primus Labs, gave Jensen Farms 95% and 96% food safety grades despite several deficiencies, said the Report on the Investigation of the Outbreak of Listeria monocytogenes in Cantaloupe at Jensen Farm.

The report, which was collected by the US House of Representatives’ Committee on Energy and Commerce, was accompanied by a letter to FDA commissioner Margaret Hamburg urging a review of third-party auditing.

The contamination, which was the deadliest US foodborne outbreak in over 25 years, infected a total of 146 people across 28 states, caused 30 deaths and led to the miscarriage of a child, according to the Centers for Disease Control and Prevention (CDC).

Probable causes

The report found that a 2011 audit failed to penalise Jensen Farms for not using an antimicrobial solution, such as chlorine, in its cantaloupe washing process.

“The failure to use an anti-microbial wash was not consistent with agency guidance and was a probable cause of the contamination,” ​the document said.

FDA officials emphasised to investigators that new processing equipment at the facility and the decision to use a washing technique not involving chlorinated water were two probable causes of the outbreak.

“According to FDA, the outbreak would have likely been prevented if Jensen Farms has maintained its facilities in accordance with existing FDA guidance,” ​added the report.

“In the case of cantaloupe processing, FDA has no specific regulations, only guidance.”

“The guidance which Bio Food Safety did not consider in its audit represents the agency’s best and most timely advice on how processing should be handled.”

“Superior” ratings

Primus Labs, which has previously audited for Jensen Farms, subcontracted to Bio Food Safety Inc for a 5 August 2010 audit.

Jensen Farms was given a 95% “superior”​ rating – despite a fall in standards on several occasions.

At this time, the facility used chlorine as an antimicrobial solution in the washing of cantaloupes.

The company later dropped the use of chlorine as an antimicrobial solution.

Bio Food Safety was again subcontracted by Primus Labs to perform an audit at Jensen Farms’ packing plant in July 2011.

On this occasion, Jensen Farms again received a 96% “superior”​ grade, despite three “major deficiencies,” ​which did not include the removal of an antimicrobial solution in the washing process.

Despite not being marked-down, the auditor noted on the front page of the Jensen Farms report that “no anti-microbial solution is injected into the water of the wash station.”

"Numerous problems"

In a letter accompanying the report, members of the House of Representatives urged FDA Commissioner Margaret Hamburg to closely review the report.

“We urge you to review closely the information uncovered during our investigation. In particular, the investigation identified significant problems with the third-party inspection system used by growers and distributors to ensure the safety of fresh produce,” ​the letter said.

“This auditing system is often the first and only line of defence again a deadly food borne disease outbreak.”

“The results of the investigation released today reveal numerous problems with the third party auditing system used to inspect the Jensen Farms cantaloupes. These problems are unlikely to be limited to Jensen Farms, however.”

Related topics: Regulation, Food safety

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