FDA Suspends Sunland’s Food Facility Registration

The agency’s action, taken under authority conferred on FDA by the Food Safety Modernization Act (FSMA), follows on the heels of a determination that “…food manufactured, processed, packed, received, or held by [the] facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and that [the] facility created, caused, or was otherwise responsible for such reasonable probability.”

Peanut butter manufactured in Sunland, Inc.’s Portales, New Mexico facility was responsible for at least 41 cases of Salmonella Bredeney infections in 20 US states, according to CDC’s most recent update, published on November 8th. Ten of the 41 outbreak victims were hospitalized.

In announcing this first ever use of FDA’s suspension powers under FSMA, the agency released the following statement:

In the interest of protecting public health, the U.S. Food and Drug Administration suspended the food facility registration of Sunland Inc., a producer of nuts, and nut and seed spreads. Registration with the FDA is required for any facility that manufactures, processes, packs, or holds food for consumption in the United States. If a facility’s registration is suspended, that facility is prohibited from introducing food into interstate or intrastate commerce.

The fact that peanut butter made by the company has been linked to an outbreak of Salmonella Bredeney that has sickened 41 people in 20 states, coupled with Sunland’s history of violations led FDA to make the decision to suspend the company’s registration.

This was the FDA’s first use of its registration suspension authority, under the Food Safety Modernization Act. This new authority enables the agency to take this action when food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and other conditions are met.

A review of Sunland Inc.’s product testing records showed that 11 product lots of nut butter showed the presence of Salmonella between June 2009 and September 2012. Between March 2010 and September 2012, at least a portion of 8 product lots of nut butter that Sunland Inc.’s own testing program identified as containing Salmonella was distributed by the company to consumers.

Additionally, during its inspection of the plant in September and October 2012, the FDA found the presence of Salmonella in 28 environmental samples (from surfaces in production or manufacturing areas) and in 13 nut butter product samples and one product sample of raw peanuts. Four of the peanut butter product samples showed the presence of the outbreak strain of Salmonella Bredeney.

The suspension order offers Sunland, Inc. the opportunity to request an informal hearing on certain issues related to the order. If, after providing this opportunity, the FDA determines that the suspension remains necessary, the FDA will require Sunland, Inc. to submit a corrective action plan to address the immediate problems and to implement a sustainable solution to those problems in a sound scientific manner. The FDA will reinstate Sunland, Inc.’s registration only when FDA determines that the company has implemented procedures to produce safe products.

In its letter of notification to Sunland’s President, FDA referred to a number of conditions and company actions that formed the basis for its decision, including:

Investigation by CDC and FDA of a multistate outbreak of Salmonella Bredeney led to a determination that Trader Joe’s™ brand Valencia Creamy Salted Peanut Butter made with Sea Salt was the likely source of the outbreak;
Sunland was the sold manufacturer of the implicated peanut butter;
Evidence collected by FDA in response to the outbreak, including the company’s own testing records, environmental and finished product samples analyzed by FDA and observations made during FDA’s inspection of the facility established that nut butter and nut products manufactured, processed, packed and held by Sunland are contaminated with Salmonella or are at risk of contamination with Salmonella;
Sunland’s own testing records revealed that third party testing identified the presence of Salmonella spp. in at least 40 finished products from 11 finished product lots and eight sets of environmental samples between June 2009 and September 2012; and
Sunland distributed at least a portion of eight lots of peanut and almond butter between March 1, 2010 and September 2012 after composite testing revealed the presence of Salmonella.

The complete text of the letter can be found on FDA’s website.

Sunland’s quality assurance philosophy clearly was “keep testing until we get a Salmonella-negative result; then ship the product.” This is an approach that has been adopted all too frequently in the food industry. I have encountered it in Canada; I have encountered it in the US. It is ethically incorrect. It is scientifically incorrect.

In a word, it is WRONG.

Sunland vs. FDA: Who Should We Believe?

At no time in its twenty-four year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms.

– Jimmie Shearer, President and CEO, Sunland, Inc.

On November 14, 2012, FDA issued the following update to its investigation of the Salmonella Bredeney peanut butter outbreak.

“November 14, 2012 – FDA posts observations from recent inspection at Sunland Inc.

The FDA has made the observations from its recent inspection of Sunland Inc. publicly available. This inspection was conducted between September 17 and October 16, 2012, and became part of the investigation of the Salmonella Bredeney outbreak linked to peanut butter made by Sunland Inc.

During this inspection investigators found that conditions in the company’s facility, the company’s manufacturing processes, and the company’s testing program for Salmonella may have allowed peanut butter that contained Salmonella to be distributed by the company.

The FDA found that between June of 2009 and August of 2012, Sunland Inc. had distributed, or cleared for distribution, portions of 11 lots, or daily production runs, of peanut or almond butter after its own testing program identified the presence of at least one of nine different Salmonella types (Arapahoe, Bredeney, Cerro, Dallgow, Kubacha, Mbandaka, Meleagridis, Newport, and Teddington) in those lots. Two of these lots showed the presence of the outbreak strain of Salmonella Bredeney.

Equally important, five product samples collected and analyzed by FDA from Sunland Inc. showed the presence of Salmonella, but had not been identified as containing Salmonella by Sunland Inc.’s internal testing. Among those products were peanut butter and shelled raw peanuts. Two of these samples showed the presence of the outbreak strain of Salmonella Bredeney.

Additionally, during its inspection of the plant in September and October 2012, the FDA found the presence of Salmonella in 28 environmental samples. Three of these samples showed the presence of the outbreak strain of Salmonella Bredeney.

Upon identifying the contaminated peanut butter, FDA investigators informed the company and called for corrective action. On October 4, 2012 Sunland Inc. expanded its ongoing recall to include all products made in the Sunland Inc. nut butter production facility between March 1, 2010 and September 24, 2012.

Upon identifying the contaminated shelled raw peanuts, FDA investigators informed the company and again called for corrective action. On October 12, 2012 Sunland Inc. expanded its ongoing recall to include raw and roasted shelled and in-shell peanuts sold in quantities from 2 ounces to 50 pounds which are within their current shelf life or have no stated expiration date.

Additionally, investigators found that employees improperly handled equipment, containers, and utensils used to hold and store food. Employees handling peanut products wiped gloved hands on street clothes and other times failed to wash their hands or change gloves. There were no hand washing sinks in the peanut processing building production or packaging areas and employees had bare-handed contact with ready-to-package peanuts.

There were no records documenting the cleaning of production equipment. The super-sized bags used by the firm to store peanuts were not cleaned despite being used for both raw and roasted peanuts. There was a leaking sink in a washroom which resulted in water accumulating on the floor, and the plant is not built to allow floors, walls and ceilings to be adequately cleaned.

Finally, investigators found that raw materials were exposed to potential contamination. Raw, in-shell peanuts were found outside the plant in uncovered trailers. Birds were observed landing in the trailers and the peanuts were exposed to rain, which provides a growth environment for Salmonella and other bacteria. Inside the warehouse, facility doors were open to the outside, which could allow pests to enter.

The FDA is currently evaluating Sunland Inc.’s official response to FDA’s observations from the inspection.”

Yesterday – November 15th – Sunland responded with this statement:

“At no time in its twenty four year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms. The Company has followed internal testing protocols that it believed resulted in the isolation and destruction of any product that did not pass the test designed to detect the presence of any contaminants. In every instance where test results indicated the presence of a contaminant, the implicated product was destroyed and not released for distribution. The Company believed at all times that its response was sufficiently robust such that any product which might be contaminated was isolated and destroyed.

Sunland, Inc. continues to cooperate openly with FDA to address matters related to the recent recall of its products and the inspection of its manufacturing facilities. Sunland has submitted a comprehensive point by point response to the Form 483 observations issued at the close of the inspection. The Company’s response is currently under review by the agency. We believe that drawing any inferences much less conclusions about the Company’s practices based solely on the observations as set forth in the Form 483 without considering the Company’s response would be wholly premature and unduly prejudicial to Sunland. The Company believes that its response to the Form 483 will not only help the agency understand the Company’s decision-making process but also lead the agency to confirm that such decision-making was, at all times, conducted in good faith. In deference to the agency’s review process, the Company will not publicly discuss its responses until the agency has completed its review.”

Sunland has not denied that contaminants were found. Nor has it denied that multiple strains of Salmonella were present at various times and in various locations, in its finished products, its raw peanuts, and its production environment.

How does a food processor allow this magnitude of contamination to exist in its finished products and in its production facility for more than three years? What does this say about the ethics of the company’s owners and management?

Or has ethical behavior become an oxymoron in the food industry?

Sunland Knowingly Shipped Contaminated Peanut Butter

“Since 2009, your firm has distributed lots of peanut butter and nut butters that were positive for Salmonella. The following is a list of products since 2009 that have been manufactured by your firm, have tested positive for Salmonella by your firm’s internal testing program, and were at least partially distributed by your firm.”

– FDA Form 483, issued October 29, 2012

It’s Peanut Corporation of America all over again.

Earlier today, FDA released a series of Enterprise Inspection Reports and Form 483 reports issued following inspections of Sunland Inc.‘s production facilities in Portales, New Mexico from as long ago as 2007.

The company, whose peanut butter was definitively linked to an outbreak of Salmonella Bredeney that sickened at least 41 people from 20 states, has known about its Salmonella contamination problems since at least June 2009. Somehow, this information escaped the notice of the company’s customers – including Trader Joe’s – its third party auditors, and FDA inspectors for more than 2 years.

According to company records reviewed by FDA, Sunland found Salmonella contamination in its nut butters (peanut and almond) on more than 20 occasions, including findings of Salmonella Newport in 2009, Salmonella Dallgow in 2010, Salmonella Dallgow, Salmonella Arapahoe, Salmonella Teddington, Salmonella Cerro, Salmonella Mbandaka and Salmonella Kubacha in 2011, and Salmonella Bredeney and Salmonella Meleagridis in 2012.

FDA’s own in-depth inspection – carried out in September and October 2012 after epidemiologists pointed to Sunland’s peanut butter as the likely source of an outbreak of Salmonella Bredeney – found Salmonella Bredeney in samples of peanut butter, as well as Salmonella Senftenberg, Salmonella Montevideo, Salmonella Bredeney, Salmonella Mbandaka, Salmonella Meleagridis, and Salmonella Anatum in the production plant environment.

That’s more strains of Salmonella than many labs maintain in their reference collection!

In addition to turning a blind eye to the contamination that pervaded its operations since 2009, Sunland’s management ignored standard Good Manufacturing Practices, as evidenced by the following litany of “Observations” reported by FDA in October 2012:

Observation 1: Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

Observation 2: Failure to handle equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination.

Specifically, the production and packaging lines of equipment in the Peanut Butter Plant were not cleaned after each time Salmonella was isolated from peanut and nut butter products between 2009 and 2012.

The … packaging equipment in the small packaging room of the Peanut Plant is not effectively cleaned between raw and roasted peanuts. Cleaning consists of wiping off non-food contact surfaces with dry paper towels, sweeping underneath and around equipment, as well as vacuuming excess dust.

Tote mesh bags utilized by your firm for storing bulk peanuts are not effectively cleaned between storage o f raw and treated (roasted and/or brined) peanuts. The tote bags are considered multi-use, and re-used for both raw and roasted peanuts.

Firm does not clean production and packaging equipment between runs of various allergen-containing products.

Observation 3: Food contact surfaces used for manufacturing low-moisture food were wet at time of use.

Observation 4: The design and workmanship of equipment does not allow proper cleaning.

Observation 5: Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles, dirt, and organic matter and the opportunity for growth of microorganisms.

Observation 6: Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.

Observation 7: Plumbing is not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant.

Observation 8: The plant is not constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair.

Observation 9: Failure to store raw materials in a manner that protects against contamination.

From 9/17112-10/2112, raw, in-shell peanuts were observed outside in uncovered trailers and open to the elements. Birds too numerous to count were observed flying over, and landing on peanuts in the trailers.

On 9/28/12, [FDA inspectors] observed the weather as overcast and rainy, seven open trailers filled with peanuts were observed stored uncovered on the front of [the] property exposed to moisture from the weather.

Observation 10: Effective measures are not being taken to exclude pests from the processing areas.

As for the company’s compliance history, consider the following:

In 2003, FDA cited the following problems: (1) the firm’s plumbing constitutes a source of contamination to food; (2) effective measures were not being taken to protect against the contamination of food on the premises by pests; (3) the firm failed to provide adequate screening or other protection against pests; (4) the firm failed to hold rework materials in bulk or in suitable containers so as to protect against contamination; and (5) the firm failed to maintain the buildings in repair sufficient to prevent food from becoming adulterated.

In 2007, FDA cited the following problems: (1) the firm failed to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination; (2) the firm failed to take reasonable precautions to ensure that production procedures do not contribute contamination from any source; (3) employees were observed not washing and sanitizing hands thoroughly in an adequate hand washing facility before starting work and after each absence from the work station; (4) effective measures were not being taken by the firm to protect against the contamination of food on the premises by pest (a repeat observation); (5) the firm failed to store raw materials in a manner that protects against contamination; and (6) the firm failed to maintain buildings in repair sufficient to prevent food from becoming adulterated (a repeat observation).

In 2009, FDA cited the following problems: (1) the firm failed to manufacture foods under conditions and controls necessary to minimize the potential of microorganisms and contamination (a repeat observation); (2) the firm failed to take all reasonable precautions to ensure that production procedures did not contribute contamination from any source (a repeat observation); (3) failure to take all reasonable measures and precautions to ensure personnel cleanliness by utilizing effective hair restraints and ensuring that beard covers were worn in an effective manner; (4) failure to ensure employees washed/sanitized their hands properly when returning from the work station (a repeat observation); (5) failure to maintain equipment used to hold food ingredients in a manner that protects them from contamination. Also, FDA found Salmonella in an environmental sample taken during its 2009 inspection.

In 2010, FDA cited the following problems: (1) All reasonable precautions are not taken to ensure that production · procedures do not contribute contamination from any source; (2) Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests; (3) The plant is not constructed in such a manner as to allow floors to be kept in good repair; (4) Failure to wear beard covers in an effective manner; (5) The design and construction of equipment and utensils fails to preclude the adulteration of food with contaminants.

In 2011, FDA cited the following problems: (1) Failure to store raw materials in a manner that protects against contamination; (2) Failure to provide adequate screening or other protection against pests.

Am I the only one who doesn’t understand what’s going on here?

Where were the company’s customers? Did they never visit the production plant?

Where was Silliker Laboratories, the company’s third party auditor? Did they ever visit the production plant or review the company’s internal lab results?

AND WHERE THE HELL WAS FDA? Why did the agency not review Sunland’s internal lab results and production/distribution records until after the company’s negligence resulted in a food poisoning outbreak?

If this is an example of “Food Safety Modernization” in action, please give me the Good Old Days.