Thursday, November 4, 2010

FDA Vindicates Texas Mandatory Closure of Sangar Produce

Feds confirm state's Listeria monocytogenes finding; release inspection report
(Updated November 4, 2010)

The Texas Department of State Health Services (DSHS) ordered the closure of Sangar Produce & Processing Co. (San Antonio) on October 20th, after finding Listeria monocytogenes in chopped celery supplied by the company to schools and institutions. The chopped celery was linked to ten cases of listeriosis – five of them fatal – in three counties.

The initial report by DSHS advised that six of the ten cases, and four of the fatalities, had been linked to the consumption of chopped celery from Sangar; the remaining four cases were a genetic match for the celery strain. Since October 20th, according to Carrie Williams of DSHS, one of the four remaining cases has been linked to Sangar, leaving just three cases still under investigation. No new cases have been reported since October 20th.

The state took its drastic action after Sanger's management refused a request for voluntary recall. The company insisted that its products were safe, and that Texas mishandled the sampling and analysis.

FDA began its own investigation of Sangar's operations on October 14th. During an intensive inspection that lasted until October 26th, the federal agency examined the operations of the facility and took its own samples for lab testing.

FDA has confirmed unequivocally the Texas DSHS test results. The federal agency found Listeria monocytogenes matching the outbreak strain in "... processed celery and in multiple locations in the plant environment, including on food contact surfaces." FDA released a statement dated November 3rd, which reads as follows:
On November 2, 2010, The Food and Drug Administration (FDA) released results of its laboratory testing of processed finished product and environmental samples taken from SanGar Fresh Cut Produce, San Antonio, Texas on October 14-15. The results indicate the presence of Listeria monocytogenes, a bacterium that can cause severe illness, in processed celery and in multiple locations in the plant environment, including on food contact surfaces. The listeria identified in FDA samples matches the DNA fingerprint of the clinical cases of listeriosis reported by the Texas Department of State Health Services.

As part of its joint investigation with Texas state officials, the FDA also inspected the SanGar company’s premises and issued a summary of its findings to the firm on October 26. The Texas DSHS ordered SanGar to stop processing food on October 20, 2010 and to recall all product shipped from the San Antonio plant since January. FDA continues to work closely with Texas food safety officials to review corrective actions being taken by the company to eliminate the presence of Listeria monocytogenes at its facility.

FDA's investigation report (FDA Form 483), also released November 3frd, details a list of 19 observations, summarized below. To read the complete report, please follow the live link to the complete Form 483.
Observation 1. Failure to take necessary precautions to protect against contamination of food and food contact surfaces with microorganisms.
Observation 2. Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials.
Observation 3. Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.
Observation 4. Personnel with adverse health conditions are not instructed to report to their supervisors.
Observation 5. Failure to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food.
Observation 6. Failure to take apart equipment as necessary to ensure thorough cleaning.
Observation 7. Failure to take effective measures to protect finished food from contamination by raw materials and refuse.
Observation 8. Failure to store raw materials in a manner that protects against contamination.
Observation 9. The design, construction, and use of equipment and utensils fails to preclude the adulteration of food with contaminants.
Observation 10. Failure to maintain equipment, containers, and utensils used to store food in a manner that protects against contamination.
Observation 11. Lack of adequate drainage of areas which may contribute to contamination of food by seepage, food-borne filth, and providing a breeding place for pests.
Observation 12. Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated.
Observation 13. The plant is not constructed in such a manner as to allow floors and walls to be adequately cleaned and kept clean and kept in good repair.
Observation 14. Plumbing constitutes a source of contamination to food, water supplies, equipment, and utensils.
Observation 15. Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.
Observation 16. Lack of a sanitary towel service or suitable hand drying devices.
Observation 17. Hand-washing facilities lack running water of a suitable temperature.
Observation 18. Failure to provide adequate screening or other protection against pests.
Observation 19. Appropriate training in food handling techniques and food protection principles has not been provided to food handlers.

This is the company that supplied contaminated produce to high-risk population groups – school children and the elderly – and declined to initiate a recall when presented with clear, scientific evidence of the link between its chopped celery and six cases of listeriosis (and a probable link with four other cases).

There is no doubt in my mind that the number of illnesses and deaths would have continued to mount if Texas had not wielded its mandatory recall/closure authority.

Sadly, yesterday's election results make it highly unlikely that FDA will be armed by Congress with similar authority in the foreseeable future.

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  1. "Sadly, yesterday's election results make it highly unlikely that FDA will be armed by Congress with similar authority in the foreseeable future."

    would you explain this statement, please?

  2. Congress operates on a 2-year cycle. This fall, Congress will convene a so-called "lame-duck" session, populated by the Representatives and Senators who were elected in 2008 and earlier (the new group takes office in January), many of whom either are retiring or lost their bid for reelection.

    All pending legislation, including the pending Food Safety bill that includes a provision giving FDA mandatory recall authority, will die if not passed and signed into law by year-end.

    Before the election recess, passage of this bill in the Senate was being blocked by means of a parliamentary procedure by Senator Coburn (Republican from Oklahoma), who was insisting on knowing how all of the provisions of the bill would be funded prior to voting. Senator Coburn was just reelected with 70% of the vote in his state.

    Congress must deal with budget issues and other pending legislation before year end. These will probably take priority (in my opinion), just as they have done for the past year and a half.

    It is my "gut feel" that a House with a Republican majority and a Senate with a very slim Democratic majority will have a great deal of difficulty in finding common ground to restart and complete the food safety legislation process from scratch in 2011.


  3. Dr. Entis, you have inaccurately described Sen. Coburn's actions and stated reasons for doing what he did on S 510.

    His “Detailed Concerns about S. 510, the FDA Food Safety Modernization Act of 2010” are at The transcript of his 9-23-10 debate with Sen. Durbin is at

    As Dr. Coburn is a member of the committee overseeing S 510, his position has been well-known for over a year and a half. Rather than "block[ing S 510] by a parliamentary procedure," Dr. Coburn was stopping the use of a "parliamentary procedure" to avoid open debate on S 510. And Sen. Reid and all 6 bill managers (3 of whom were Republicans supporters of it) had been informed that he would do exactly what he did. They could have brought it up earlier but didn't. Instead, Sen. Reid chose to politicize a truly (and, to me, sadly) bi-partisan bill by lying to the American people about what was happening. Apparently, it was part of his obstructionism theme for the election.

    S 510 is an industrial-size-only approach to food safety that provides political cover for the FDA to use its existing powers to mandate the style of food safety regulation that it wants to have. The CBO estimate of its projected cost ought to be a terrible embarrassment to the CBO. It contains no money for the cost of inspecting the million plus farms growing fruits and/or vegetables as would be required under the rules currently being written to comply with Sec. 105 Standards for Produce Safety.

    As a small grower, distributor and retailer of local, healthy food who has given up 60+ hours a week for 14 months trying to engage supporters of S 510 in substantive discussions, I am sad that a well informed, obviously dedicated, food safety professional like you is ignorant of facts like those I've just cited.

    I am writing this not so much for publication as a request to you to open yourself to information about S 510 from a source other than Make Our Food Safe coalition and those of similar ilk. I can be reached by phone at 828/669-4003 8 AM - 8 PM Eastern time and by e-mail at



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