FDA flexed its new regulatory muscle as granted through FSMA and shut down Sunland Foods, the maker of contaminated Trader Joe's Peanut Butter. Sunland was planning to reopen the processing facility this week, but FDA suspended the facility's registration due to a 'reasonable probability' that their product could cause serious health problems. Numerous issues in the facility had been cited (http://pennstatefoodsafety.blogspot.com/2012/11/fda-investigation-report-on-sunland.html) including FDA's assertion that Sunland knowingly shipped contaminated product. Sunland denies this claim.
Now it is up to the company to prove its case in court in order to resume operations.
FDA's decision to shut a facility down begins a new chapter for food processors and their interaction with FDA under FSMA. Most consumers would probably agree that this facility deserved to be closed. But we don't know to what degree the facility had made steps to improve since the initial recall back in late September. (http://pennstatefoodsafety.blogspot.com/2012/09/supplier-of-trader-joes-peanut-butter.html) Was Sunland Foods unable to get up to standard in the last 2 months, or were there issues so numerous and/or bad that FDA still deemed the facility a risk to consumers? What will be interesting moving forward is how FDA will use this new power. Will it be used as a preventive tool, shutting plants down before the products they produce causes illness? And if so, to what degree of risk will federal inspectors be willing to accept? Listeria in a drain? Salmonella in a product that is not fully cooked? Or will it be used as a punitive action - a way to make a facility involved in an outbreak prove that it has made the necessary changes?
USAToday Health and Wellness 6:17PM EST November 26. 2012 -
WASHINGTON (AP) — The Food and Drug Administration halted operations of the country's largest organic peanut butter processor Monday, cracking down on salmonella poisoning for the first time with the new enforcement authority the agency gained in a 2011 food safety law.
FDA officials found salmonella all over Sunland Inc.'s New Mexico processing plant after 41 people in 20 states, most of them children, were sickened by peanut butter manufactured at the Sunland plant and sold at Trader Joe's grocery chain. The FDA suspended Sunland's registration Monday, preventing the company from producing or distributing any food.
The food safety law gave the FDA authority to suspend a company's registration when food manufactured or held there has a "reasonable probability" of causing serious health problems or death. Before the food safety law was enacted early last year, the FDA would have had to go to court to suspend a company's registration.
Sunland had planned to reopen its peanut processing facility on Tuesday and a spokeswoman said before the
FDA's announcement Monday that the company hoped to be selling peanut butter again by the end of the year. The spokeswoman didn't have immediate comment on the suspension.
The company now has the right to a hearing and must prove to the agency that its facilities are clean enough to reopen.
Michael Taylor, the FDA's deputy commissioner for foods, said the FDA's ability to suspend a registration like this one is a major step forward for the agency.
"Consumers can be assured that products will not leave this facility until we determine they have implemented preventive measures that are effective to produce safe products," Taylor said.
Sunland Inc. is the nation's largest organic peanut butter processor, though it also produces many non-organic products. The company recalled hundreds of organic and non-organic nuts and nut butters manufactured since 2010 after Trader Joe's Valencia Creamy Peanut Butter was linked to the salmonella illnesses in September.
In addition to Trader Joe's, Sunland sold hundreds of different peanut products to many of the nation's other large grocery chains, including Whole Foods, Safeway, Target and others.
In a monthlong investigation in September and October, after the outbreak linked to processor Sunland and to Trader Joe's, FDA inspectors found samples of salmonella in 28 different locations in the plant, in 13 nut butter samples and in one sample of raw peanuts.
The agency also found improper handling of the products, unclean equipment and uncovered trailers of peanuts outside the facility that were exposed to rain and birds.
The FDA said that over the past three years, the company shipped products even though portions of their lots, or daily production runs, tested positive for salmonella in internal tests. The agency also found that the internal tests failed to find salmonella when it was present.
FDA inspectors found many of the same problems — including employees putting their bare fingers into empty jars before they were filled, open bags of ingredients, unclean equipment, and many other violations — in a 2007 inspection. Similar problems were recorded by inspectors in 2009, 2010 and 2011, though government officials didn't take any action or release the results of those inspections until after the illnesses were discovered this year.
In a statement earlier this month, Sunland officials denied that they knowingly shipped tainted products.
"At no time in its 24-year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms," Sunland president and CEO Jimmie Shearer said in a statement on the company's website. "In every instance where test results indicated the presence of a contaminant, the implicated product was destroyed and not released for distribution."
A separate peanut butter outbreak in 2009 not related to Sunland was linked to hundreds of illnesses and nine deaths.
Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Now it is up to the company to prove its case in court in order to resume operations.
FDA's decision to shut a facility down begins a new chapter for food processors and their interaction with FDA under FSMA. Most consumers would probably agree that this facility deserved to be closed. But we don't know to what degree the facility had made steps to improve since the initial recall back in late September. (http://pennstatefoodsafety.blogspot.com/2012/09/supplier-of-trader-joes-peanut-butter.html) Was Sunland Foods unable to get up to standard in the last 2 months, or were there issues so numerous and/or bad that FDA still deemed the facility a risk to consumers? What will be interesting moving forward is how FDA will use this new power. Will it be used as a preventive tool, shutting plants down before the products they produce causes illness? And if so, to what degree of risk will federal inspectors be willing to accept? Listeria in a drain? Salmonella in a product that is not fully cooked? Or will it be used as a punitive action - a way to make a facility involved in an outbreak prove that it has made the necessary changes?
FDA halts company's peanut butter operations
The FDA suspended Sunland's registration over salmonella concerns.
USAToday Health and Wellness 6:17PM EST November 26. 2012 -
WASHINGTON (AP) — The Food and Drug Administration halted operations of the country's largest organic peanut butter processor Monday, cracking down on salmonella poisoning for the first time with the new enforcement authority the agency gained in a 2011 food safety law.
FDA officials found salmonella all over Sunland Inc.'s New Mexico processing plant after 41 people in 20 states, most of them children, were sickened by peanut butter manufactured at the Sunland plant and sold at Trader Joe's grocery chain. The FDA suspended Sunland's registration Monday, preventing the company from producing or distributing any food.
The food safety law gave the FDA authority to suspend a company's registration when food manufactured or held there has a "reasonable probability" of causing serious health problems or death. Before the food safety law was enacted early last year, the FDA would have had to go to court to suspend a company's registration.
Sunland had planned to reopen its peanut processing facility on Tuesday and a spokeswoman said before the
FDA's announcement Monday that the company hoped to be selling peanut butter again by the end of the year. The spokeswoman didn't have immediate comment on the suspension.
The company now has the right to a hearing and must prove to the agency that its facilities are clean enough to reopen.
Michael Taylor, the FDA's deputy commissioner for foods, said the FDA's ability to suspend a registration like this one is a major step forward for the agency.
"Consumers can be assured that products will not leave this facility until we determine they have implemented preventive measures that are effective to produce safe products," Taylor said.
Sunland Inc. is the nation's largest organic peanut butter processor, though it also produces many non-organic products. The company recalled hundreds of organic and non-organic nuts and nut butters manufactured since 2010 after Trader Joe's Valencia Creamy Peanut Butter was linked to the salmonella illnesses in September.
In addition to Trader Joe's, Sunland sold hundreds of different peanut products to many of the nation's other large grocery chains, including Whole Foods, Safeway, Target and others.
In a monthlong investigation in September and October, after the outbreak linked to processor Sunland and to Trader Joe's, FDA inspectors found samples of salmonella in 28 different locations in the plant, in 13 nut butter samples and in one sample of raw peanuts.
The agency also found improper handling of the products, unclean equipment and uncovered trailers of peanuts outside the facility that were exposed to rain and birds.
The FDA said that over the past three years, the company shipped products even though portions of their lots, or daily production runs, tested positive for salmonella in internal tests. The agency also found that the internal tests failed to find salmonella when it was present.
FDA inspectors found many of the same problems — including employees putting their bare fingers into empty jars before they were filled, open bags of ingredients, unclean equipment, and many other violations — in a 2007 inspection. Similar problems were recorded by inspectors in 2009, 2010 and 2011, though government officials didn't take any action or release the results of those inspections until after the illnesses were discovered this year.
In a statement earlier this month, Sunland officials denied that they knowingly shipped tainted products.
"At no time in its 24-year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms," Sunland president and CEO Jimmie Shearer said in a statement on the company's website. "In every instance where test results indicated the presence of a contaminant, the implicated product was destroyed and not released for distribution."
A separate peanut butter outbreak in 2009 not related to Sunland was linked to hundreds of illnesses and nine deaths.
Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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