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Thumb Oilseed Producers’ Cooperative (Ubly, MI) recalled soybean flour and soy meal today, due to possible Salmonella contamination. The recalled products were distributed to wholesale customers in Illinois, Vermont, Minnesota, Pennsylvania, Wisconsin, New Hampshire and Canada, for use in the manufacture of human and animal food.

This is the second time in less than two years that Thumb Oilseed has run afoul of Salmonella.

On February 25, 2010, Thumb Oilseed Producers’ Cooperative (Ubly, MI) recalled shipments of soybean grits and flour, because the soy products had “…the potential to be contaminated with Salmonella…” The recalled soybean grits and flour were distributed to a “limited group” of wholesale customers in the USA.

According to Thumb’s recall notice, the recall resulted from “…routine sampling programs conducted by the company and its wholesale customers.” The company did not reveal that FDA had been inspecting Thumb’s manufacturing facility since January 28th, and had completed its inspection on February 23rd – two days prior to the date of the recall notice.

In their Form 483 (Inspectional Observations) report, handed to the company at the completion of the inspection, FDA investigators documented a serious of failures on the part of Thumb, including an egregious disregard for public safety, as witnesses by the details of Observation 1, as follows (emphasis added):

Food which has become contaminated to the extent of being adulterated within the meaning of the Act is not rejected or if permissible, treated or processed to eliminate the contamination..

Specifically, in the last fourteen months of production of lots of Non-GMO soy flour, your firm released finished product non-GMO soy flour found to be positive for Salmonella sp. on two separate occasions.

a. On 12/22/08, you had a private laboratory analyze Non-GMO soy flour lot TF121608 for Salmonella sp. The lab reported this lot was positive for Salmonella sp. on 12/22/08. The lot was subsequently retested on 01/12/09 by the same private laboratory, and released into commerce in four different deliveries: {quantity redacted} 40-1b. bags on 01/13/09; {quantity redacted} 40-1b. bags on o2/04/09; approximately {quantity redacted} 40-lb.bags on 09108/09; and {quantity redacted} 40-1b. bags on 03/27/09.

b. On 10102/09, you had a private laboratory analyze Non-GMO soy flour lot TF092409 for Salmonella sp. The lab reported this lot was positive for Salmonella sp. 10/02/09. The entire lot, a total of 4,random weight totes, was subsequently released into commerce as animal feed on 10/19/09.

Other observations reported by the FDA inspection team included:

Observation 2: Failure to manufacture, package, and store foods under conditions and controls necessary to minimize contamination.

Observation 3: Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces.

Observation 4: Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.

Observation 5: Effective measures are not being taken to exclude pests from the processing areas.

The firm’s response to FDA’s observations evidently was not pleasing to the agency; FDA issued a formal Warning Letter to Joann F. Rutkowski, COO of Thumb Oilseed on June 24, 2010. In its letter, FDA informs Ms. Rutkowski that its lab analyses found Salmonella in forty-three locations inside Thumb’s manufacturing plant. And FDA recovered Salmonella from a sample of the company’s finished product soy flour.

All of the Salmonella found in the plant’s environment and in the finished soy flour were a single serotype – Salmonella senftenberg – and all produced indistinguishable “DNA fingerprint” patterns.

The Warning Letter ended by requesting that the company “…notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions, including any further specific steps that you have taken to correct the noted violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.”

Whatever steps Thumb Oilseed may have taken in the past year to correct all of their breaches of sanitation and Current Good Manufacturing Practices clearly weren’t enough. And its failure to clean up a dirty mess will be expensive for itself, its customers, and consumers – who ultimately pay the bill.

Thumb Oilseed’s last recall triggered several “secondary” recalls, by companies who used the contaminated soy products as ingredients. These included:

I have every reason to expect the same pattern to repeat itself.
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