Setton Pistachio Claims It "Never Knowingly" Shipped Tainted Product

After the recall since March of a couple million pounds of pistachios in over 660 separate products, Setton Pistachio sent its Chief Operating Officer (COO) out to deny the California company continued to ship its seeds after discovering they were contaminated with salmonella.

In doing so, Setton’s COO Mia Cohen took exception to the Food & Drug Administration’s (FDA’s) investigative report, known as a 483 for its form number.

“We adamantly disagree with portions of the 483 and we have responded accordingly…Our company never knowingly shipped pistachios potentially contaminated with Salmonella. All pistachios, which tested positive, were either reconditioned or held in quarantine and never hit the marketplace, ” Ms. Cohen told the industry site foodnavigator-usa.com.

Since FDA took pre-emptive action with Setton , there are no known illnesses associated with the massive recall. This dispute about the facts will remain between FDA and Setton. With peanuts, salmonella contamination made over 700 people sick and was responsible for nine deaths. As part of the discovery process involving victims of the Peanut Corporation of America, third party experts extensively inspected those facilities in Texas and Georgia last month.

FDA was very critical of Setton’s action to “recondition” pistachios that tested positive for salmonella. In at least one instance, the company re-roasted pistachios that tested positive for Salmonella and then blended them together with other nuts for sale.

Setton says re-conditioning is an accepted way of killing salmonella. However, there is potential for cross contamination.

Much of Setton’s defense of its action rests on its hiring of the American Council for Food Safety and Quality (known as DFA in California ) once it had positive salmonella test results.

“They conducted hundreds of tests from October to February and could find no evidence of Salmonella in our facility,” Cohen said. “There was never a suggestion from DFA not to ship.”

It should be noted that Peanut Corporation of America also had a third-party auditor that did not question its practices.

Our report on the 483 report can be found here.

Raw Milk Used To Make Mexican-Style Cheese Blamed In Utah Salmonella Outbreak

 Homemade queso fresco , a Mexican-style soft cheese made with raw milk, is being blamed by health officials for a salmonella outbreak in Utah's Salt Lake Valley.

The Salt Lake Tribune reported last week on seven salmonella cases that were being linked to someone in Kearns, Utah who was making queso fresco using raw milk from a cow on a nearby farm.

Larry Lewis, spokesman for the State Department of Agriculture, said officials believe the contaminated cheese was sold or given away to friends and neighbors, but not produced or sold commercially.

"We believe the contamination came from the raw milk," Lewis said. However, the cheese maker would not tell officials where he obtained the milk.

Health officials say the sick in Utah are suffering from "Salmonella Newport."  They believe the outbreak is more widespread than just the seven cases as other salmonella cases have been reported. For more from the SL Tribune, go here.

Food & Drug Administration (FDA) Makes Its 483 Inspection Report of Setton Pistachio Public

 

In a 483 Inspection Report released today, FDA inspectors identified multiple food-safety shortcomings at the Setton Pistachio of Terra Bella California that was linked to a Salmonella outbreak earlier this year:

1. The company detected the bacteria in roasted pistachios in October but did not change its processing procedures until March

2. In one instance, the company re-roasted pistachios that had tested positive for Salmonella and blended them together with other nuts for sale.

3. Inspectors identified a "failure to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination."

4. Specific physical problems ranged from a rusty hole in the roof above one pistachio roaster to "thick layers of dust and debris" in a packaging room.

5. Procedural shortcomings included failure to monitor roasting temperatures and allowing raw and roasted pistachios to potentially come into contact.

6. Between October 2008 and March 2009, the report noted that "there were at least eight reported Salmonella-positive test results" coming out of the Terra Bella plant. When the firm learned of the private laboratory test results, inspectors said, there were no "procedures in place" to respond appropriately.

7. Prior to January, inspectors added, the Terra Bella plant did not monitor roasting temperatures, roasting times or the depth of pistachios placed on the roasting conveyor belts.

8. Inspectors checked records for 14 lots of roasted pistachios. In a potentially dangerous step, 10 of these lots had raw pistachios packed on the same packaging equipment prior to the roasted pistachios being run.

Does this not sound just a bit like the 483 Inspection report at the Peanut Corporation of America?  Setton is just lucky they did not sicken and kill people or they may too be facing bankruptcy and jail time.  When are companies going to get a clue?

WAL*MART Cantaloupes In Carolinas And South Hill, Virginia Recalled After Testing Positive For Salmonella

 How big is "a lot?" Raleigh, NC-based L&M Companies, Inc. has recalled "one lot of whole cantaloupes because it has the potential to be contaminated with Salmonella.

One lot must be a lot because there were enough cantaloupes to fulfill the needs of Walmart Supercenter Stores in North Carolina and South Carolina, and in the Walmart Supercenter Store located at 315 Furr Street in South Hill, Virginia. The cants were sold between the 10th and 15th of this month.

No illnesses have yet been associated with the recall.

"Consumers who have purchased whole cantaloupes from these Walmart stores during this time period should not consume them, and should destroy the product," L&M said in its recall statement.

The recall comes after a cantaloupe at a small farm from which L&M Companies sources product tested positive for Salmonella. L&M has ceased shipments from this farm, and the grower continues to investigate the cause of the problem.

L&M's statement can be found on the FDA's website here.

Peanuts & Pistachios Will Mark The History Of Change At Food & Drug Administration

Few would have predicted that when history is written on the first term of the Obama Administration that peanuts and pistachios would play such prominent roles.   Those unlikely products, however, will be used by historians to demonstrate the bad old ways versus the new U.S. Food & Drug Administration (FDA).

Maybe because the new President himself came from the streets of Chicago, he went to the front lines of the country's public health challenge to select Dr. Margaret Hamburg as FDA Commissioner and Dr. Joshua Sharfstein, as her deputy.   Dr. Hamburg, an expert in biological defense and disease control, was during the 1990s the youngest person in history to serve as New York City's health commissioner.  Dr. Sharfstein, a pediatrician, came to FDA directly from heading up the Baltimore Health Department.

It is really hard to overstate how unusual it is to have two top FDA officials from the gritty streets of big cities.   Almost all previous FDA Commissioners come from academic and research backgrounds.  You can go through each biography of past FDA Commissioners here

Few had any in-the-streets experience.   LBJ's last commissioner, Dr. James Goddard, came out of the Public Health Service at a time when federal doctors wore uniforms and saw patients.   And Nixon's appointee, Dr. Herbert Lay, Jr., was known for his service as an epidemiologist for our troops in Korea and Vietnam.

But that's about it.   FDA Commissioners have not been folks who got their hands dirty, knocking down the TB rate in the Big Apple as Dr. Hamburg did or taking on the dangers of over-the-counter cold and cough medicines for children under age 2 as Dr. Sharfstein did.  The typical FDA honcho creates process, not results.

So when Sharfstein took over FDA, while waiting for Hamburg to clear the Senate, it really should have come as no surprise that he opted to recall Salmonella-contaminated pistachios before anyone got sick.

The FDA has completed its inspection of Salmonella contamination in pistachios and pistachio products at Setton Pistachio of Terra Bella, Inc., Terra Bella, Calif., and presented a 483 Inspection Report to the firm.

 

FDA Updates Its Alfalfa Sprout Investigation And Continues To Ban Their Consumption; Tells About The Seeds of Destruction

 Here are the highlights of an update just posted from the United States Food and Drug Administration (FDA) on the sprout-caused Salmonella Saintpaul outbreak that has impacted at least 14 states:

  •  A preliminary report of the investigation is available from CDC's, the Morbidity and Mortality Weekly Report, MMWR adobe portable document format icon [PDF - 114 KB].
  • Since February 2009, 235 persons from 14 states have been infected with the outbreak strain of Salmonella Saintpaul. Patients range in age from < 1 to 85 years old with reports of 3% persons hospitalized and no deaths.
  • Collaborative investigative efforts of many local, state, and federal public health, agriculture and regulatory agencies led to the implication of alfalfa sprouts.
  • The alfalfa sprouts were produced at several sprout growers and appear to involve only seeds sold by one seed company that originated from one grower which strongly suggests that the seeds were contaminated.
  • This outbreak may indicate a need to determine how well existing FDA guidance is being implemented (since it is voluntary), as well as to explore additional studies of measures that can be taken to prevent, detect, and eliminate contamination of seeds and sprouts.
  • FDA and CDC continue to recommend that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated.

 Cases Infected with the Outbreak Strain of Salmonella Saintpaul Via Alfalfa Sprouts

United States, by State, as of May 7, 2009 (n=235)

A map displaying cases infected with the outbreak strain of Salmonella Saintpaul in the United States of America, by state, as of May 7, 2009.

As of May 7, 2009, 235 persons infected with the outbreak strain of Salmonella Saintpaul have been reported from 14 states. The number of ill persons identified in each state is as follows: Nebraska (111), Iowa (35), South Dakota (38), Michigan (19), Kansas (8), Pennsylvania (7), Minnesota (5), Ohio (3), Illinois (2), Virginia (2), West Virginia (2), Florida (1), North Carolina (1), and Utah (1).

 

De Jong Bros. Farms Recalls Spinach That May Be Contaminated With Salmonella

And in news from Illinois Agriculture this morning we learn of a spinach recall due to possible Salmonella contamination.  

 

De  Jong Bros . Farms, Incorporated of Lansing, Illinois, has recalled its curly leaf spinach packages sold in 2.5 pound, 5 pound and 10 oz. bags because they have the potential to be contaminated with Salmonella. The bags were labeled with use by dates 04/24/09 through 04/28/09.

 

 The recalled spinach was distributed in Illinois, Indiana, Michigan, Minnesota and Missouri through grocery stores and restaurant wholesalers and carried lot codes K54 or K54A. Consumers who have purchased these lot codes K54 or K54A De Jong Bros. Quality Fresh curly spinach are urged to dispose of it or return it to the place of purchase.

No illnesses have yet been reported in connection with this recall. For more, check this out.

FDA Alerts Sprout Growers and Retailers About Specific Lots of Alfalfa Seed Potentially Contaminated with Salmonella

 The U.S. Food and Drug Administration (FDA) may be getting to the bottom of the problem of contaminated sprouts.   And, the very bottom appears to be the seeds.   FDA issued this statement late yesterday:

Preliminary epidemiology regarding the ongoing outbreak of illness from Salmonella Saintpaul in people who had eaten alfalfa sprouts was shared with the supplier of the seeds associated with illness. Based on this information the seed supplier made the decision to voluntarily withdraw from the market all of the alfalfa seeds bearing six digit lot numbers that start with “032.”

All seeds involved in this market withdrawal came from Italy. The seeds are in 50-pound white bags that are either paper or woven from a synthetic material, and the lot numbers in question begin with “032,” followed by a hyphen and three more digits. The bags carry a computer-generated white or yellow label, on which is printed “Distributed by Caudill Seed Company., 1402 W. Main St., Louisville KY 40203” and the lot number.

FDA has no evidence that alfalfa seeds from other lots, or sprouts grown from them, are affected by this market withdrawal. Retailers, restaurateurs, and personnel at other food-service facilities should ask their suppliers to verify that the alfalfa sprouts or seeds being provided do not come from an affected lot before buying or serving them. Suppliers who can verify that their products were not sourced from the affected lots may wish to notify their customers; likewise, retailers, restaurateurs, and food-service facilities who have verified the sources of their alfalfa products may wish to notify their customers.

Seeds from the affected lots, lot numbers beginning with 032, and sprouts grown from them, should be safely discarded, as should other products that contain the sprouts, such as sprout blends. Growers who have used seeds from the potentially contaminated lots should clean all equipment and other surfaces that came into contact with them. They should also safely discard any water that came into contact with the sprouts, and disinfect receptacles or equipment that came into contact with the water.

For all FDA has to say on sprouts, go here and here.

Why Not Recall The Seeds In the Sprout-Caused Salmonella Saintpaul Outbreak?

 The CDC reports that since mid-March, 35 persons infected with the outbreak strain of Salmonella Saintpaul have been reported from 7 states. The number of ill persons identified in each state is as follows: Michigan (17), Minnesota (4), Ohio (3), Pennsylvania (6), South Dakota (2), Utah (1), and West Virginia (2). Cases are still being reported, and possible cases are in various stages of laboratory testing, so illnesses may be reported from other states. No deaths have been reported.  State and local authorities, CDC, and FDA have linked this outbreak to eating alfalfa sprouts. Most of those who became ill reported eating raw alfalfa sprouts. Some reported eating sprouts at restaurants; others purchased sprouts at the retail level.

The initial investigation has traced the contaminated raw alfalfa sprouts to multiple sprout growers in multiple states. This suggests a problem with the seeds used, as well as the possible failure of the sprout growers involved to appropriately and consistently follow the FDA Sprout Guidance issued in 1999.  The guidance recommends an effective seed disinfection treatment immediately before the start of sprouting (such as treating seeds in a 20,000 parts per million calcium hypochlorite solution with agitation for 15 minutes) and regularly testing the water used for every batch of sprouts for Salmonella and E coli O157:H7.

This outbreak appears to be an extension of an earlier outbreak in 2009. In February and March, an outbreak of Salmonella Saintpaul infections occurred in Nebraska, South Dakota, Iowa, Kansas, and Minnesota. This outbreak was linked to raw alfalfa sprouts produced at a single facility, and the outbreak strain was indistinguishable from that of the more recently reported cases. CDC is also currently working with public health officials in several states and FDA to investigate an outbreak of Listeria monocytogenes infections linked with eating alfalfa sprouts.

So, where did the seeds come from, and why not a recall of seeds?