The Customer is King
(Verbatim • Factory Food)
You may recall Setton International Farms of Commack, N.Y., and its 150,000-square-foot Terra Bella, Calif., pistachio processing plant? The plant in whose products its customer, Kraft Foods, discovered four salmonella serotypes, leading to a Food and Drug Administration-recommended “voluntary” recall of 2 million pounds or so of pistachios?
The FDA finally decided to publicly release the results of its recent plant inspection (March 26 – April 30, 2009):
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATIONTO: Nicolo (NMI) Lapietra, General Manager
Setton Pistachio of Terra Bella, Inc.DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION 1
Failure to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
After receiving sample analysis results for your roasted pistachio products that were positive for Salmonella beginning in October 2008, your firm continued to process roasted pistachio products under the same processing conditions until March 2009. Your firm continued to process roasted pistachio products after the first private laboratory sample of your roasted pistachio product was reported positive for Salmonella and did not evaluate the adequacy of your roasting process to assure that your roasted pistachio products were free of microorganisms of public health significance. Your firm also did not attempt to determine potential routes of cross contamination within your facility between raw pistachios and roasted pistachios after your firm began receiving positive Salmonella sample results for your roasted pistachio products.
The private laboratory testing that your firm requested found Salmonella in your processed In-Shell Roasted/Salted Pistachios which was the product redacted) pounds your firm shipped on 10/14/08 to an out-of-state customer under Bill of Lading Order Number (redacted), prior to your firm receiving the private laboratory analytical results. The same In-Shell Roasted/Salted Pistachio product was returned by the aforementioned customer to your firm. Your firm then re-roasted the product and blended it into other pistachio products which were sent to other customers.
On 3/12/09, your firm shipped to an out-of-state customer your processed Roasted/Salted Pistachio Kernals (redacted) pounds under Bill of Lading Order Number (redacted), Invoice number (redacted), and (redacted) which your private laboratory testing found positive for Salmonella.
On 3/18/09, your firm shipped to an out-of-state customer your processed In-shell Roasted/Salted Pistachios (redacted) pounds under Bill of Lading Order Number (redacted) number (redacted). A sample of this product was collected and sent by your firm to a private laboratory for testing and found positive for Salmonella after your firm had shipped the product.
There were at least eight reported Salmonella-positive test results, on samples submitted by your firm of your roasted pistachios, from four third-party private laboratories from October 2008 through March 2009.
Your firm lacks adequate quality control operations and a planned/systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of the FD&C Act. When your firm was notified by your private laboratories of sample test results for your roasted pistachio products that were positive for Salmonella, your firm did not have procedures in place to assess the most appropriate response to these reported positive samples.
On 3/28/09, a large gap leading to the outside environment as large as 6” x 1 foot, was observed in the roof of your firm located above the Commercial roaster used to process pistachios (redacted). There was a rusty and broken part of the ceiling hanging from this gap. There were two other gaps leading to the outside environment observed, as large as 2” x 6”, in this ceiling above the Commercial roaster. Thick layers of dust and debris were observed on the red ceiling structures and over head pipes in the packaging room.
OBSERVATION 2
Raw materials which contain levels of microorganisms that may produce food poisoning or other diseases are not pasteurized or otherwise adequately treated.
Specifically, your firm lacks adequate controls to assure that your roasting step is evvective in destroying microorganisms of public health significance. There is no assurance that your roasting process is effective and that any of your roasted pistachios are pathogen free.
Prior to January 2009, your firm did not monitor roasting temperatures, the length of time the pistachios were exposed to heat or the depth of the pistachios on the conveyor belts that are processed through the roasters. Your firm has not calibrated your roaster temperature monitoring devices or the belt speeds of the roaster conveyor belts. The in-shell and kernal pistachio roasters are used to roast raw pistachios and also used to roast previously roasted lots of pistachios that were tested by your private laboratories and found to be adulterated with undesirable microorganisms of public health significance.
OBSERVATION 3
Proper precautions to protect food and food-contact surfaces from contamination with microorganisms cannot be taken because of deficiencies in plant construuction and design.
Specifically, your firm is not equipped with an effective air flow system to prevent cross-contamination of your finished roasted pistachio and nut products.
OBSERVATION 4
Failure to take effective measures to protect finished food from contamination by raw materials and other ingredients.
Specifically, the raw (un-roasted) pistachios and roasted pistachios were packed in the same rooms. Also, the ready-to-eat roasted pistachios were sorted int he same sort room where in-line processed raw pistachios were sorted. In addition, raw pistachios were run prior to the ready-to-eat roasted pistachios on the same equipment (i.e. roller-sorter, Bulk Line Transfer Hopper)
Your firm lacked adequate measures to prevent cross-contamination from the raw pistachio are to the finished, ready-to-eat roasted pistachio product area. Employees, forklifts, bins, detachable conveyor buckets, portable conveyor buckets, brooms, and sampling carts moved throughout the raw and roasted areas of the processing building.
Your firm lacks controls in place to assure that the red dye room processing equipment was cleaned and sanitized before and after each flavored pistachio product was run. This same processing equipment is used to process flavored pistachios containing soy and wheat which are known allergens.
When 14 lots of roasted pistachio records were reviewed, it was determined that 10 of those lots had raw pistachios packed on the same packaging equipment prior to the roasted pistachio being run…
OBSERVATION 5
Failure to maintain equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination.
Detachable/portable processing conveyor buckets, which had been cleaned, that are used to convey raw and roasted pistachio products were routinely stored outside the covered processing areas and exposed to the outside environment. Also, flexible covers used to protect the buckets did not completely cover the conveyor buckets.
OBSERVATION 6
The design of equipment and utensils fails to preclude the adulteration of food with contaiminants.
Specifically, a blackish cloth-like material was wrapped around the braces of the overflow water funnel of the dewatering screen located in the roaster room. This cloth-like material cannot be adequately cleaned or sanitized.
OBSERVATION 7
Failure to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-contact surfaces, and food-packaging materials.
Specifically, a portable air circulation fan located next to the Bulk line packaging operation had a buildup of accumulated dust and other debris on the fan blandes and fan wire guard.
Despite some apparent similarities with the recent peanut escapades, the cost of the adulterated pistachio crops appears to have fallen on industry, rather than a sickened consuming public.
I think maybe this is as it should be. Make me puke once, shame on you. Make me puke twice, shame on me. In other words, since the pistachio and peanut industries have shown me that I can’t necessarily trust them to provide my family with products that are safe to eat, I will limit my purchase of such products to those coming from producers in whom I have established a reason to trust.
Otherwise, I’ll be more than happy to rely on recent observations that indicate we’ll have a fine crop of pecans this year.
→ B.Dunn, May 23, 2009, 08 27 am
