Posted May 23, 2013
The U.S. Food and Drug Administration has issued a letter authorizing Sunland Inc., of Portales, New Mexico, to resume receiving, preparing, processing, packing, holding, and distributing food at or from its peanut butter facility. Under the terms of a Consent Decree of Permanent Injunction entered by the United States District Court for the District of New Mexico on December 21, 2012, Sunland was prohibited from manufacturing ready-to-eat food products until the firm fulfilled certain requirements, including, among others, hiring a sanitation expert and developing and implementing a sanitation control program.
Due to the steps taken by Sunland to come into compliance, FDA is lifting the company’s registration suspension. The FDA suspended Sunland’s food facility registration on November 26, 2012, following a multi-state outbreak of Salmonella Bredeney that the FDA and the Centers for Disease Control and Prevention CDC traced back to product from the facility. On December 21, 2012, FDA issued an order vacating the suspension because FDA determined, based on the requirements of the consent decree, that adequate grounds did not exist to continue the suspension action.
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Throughout the course of the investigation and response to this outbreak, the FDA regularly posted updates to keep the public informed. This summary was developed to document the milestones of the investigation and any outcomes as a reference for the public and the FDA’s partners in the investigation.
The U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and state and local public health officials investigated a multi-state outbreak of Salmonella Bredeney infections linked to Trader Joe’s Valencia Creamy Salted Peanut Butter, with a Stock Keeping Unit (SKU) identifier of 97111, made by Sunland Inc. of Portales, New Mexico.
On November 30, 2012, the Centers for Disease Control and Prevention issued a final update reporting that this particular outbreak appeared to be over. The CDC reported a total of 42 people infected with the outbreak strain of Salmonella Bredeney from 20 states: Arizona (1), California (7), Connecticut (3), Illinois (1), Louisiana (1), Massachusetts (3), Maryland (1), Michigan (1), Minnesota (1), Missouri (2), New Jersey (2), New Mexico (1), New York (2), Nevada (1), North Carolina (3), Pennsylvania (2), Rhode Island (1), Texas (5), Virginia (2), West Virginia (2).
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most people recover without treatment. However, in some people, the diarrhea may be so severe that the patient needs to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Children are the most likely to get salmonellosis. The rate of diagnosed infections in children less than five years old is higher than the rate in all other persons. Young children, the elderly, and those with compromised immune systems are the most likely to have severe infections. It is estimated that approximately 400 persons die each year with acute salmonellosis.
In September 2012, FDA became involved in this fast-moving outbreak investigation, working closely with the CDC and several state health departments, which were also conducting investigations. The collaborative investigation efforts of state, local, and federal public health and regulatory agencies indicated that Trader Joe's Valencia Peanut Butter, manufactured by Sunland, Inc. of Portales, New Mexico, was a likely source of this outbreak.
On September 20, FDA, the CDC and the state of California briefed Trader Joe’s on the status of the investigation, and the company voluntarily removed the suspected product from their store shelves. Trader Joe’s also posted a customer advisory on their internet page and initiated a recall.
FDA investigators had begun an inspection at Sunland, Inc., Portales, NM, on September 17, 2012 in response to a previous unrelated allergy complaint. When, Sunland, Inc. was identified as the manufacturer of Trader Joe’s Creamy Salted Peanut Butter the inspection was expanded to include sampling and record collection.
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 also 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 the inspection of the processing 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.
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 investigation concluded on October 16, and on November 14, the FDA made the observations from the inspection of Sunland Inc., which were documented by an FDA Form 483 (PDF - 2.55MB), publicly available. Additionally, testing conducted by the Washington State Department of Agriculture laboratory isolated the outbreak strain from an opened jar of Trader Joe’s Valencia Creamy Peanut Butter collected from a case-patient’s home.
The FDA investigation led to a number of additional recalls. On September 23, FDA and CDC briefed Sunland Inc. on the status of the investigation, and Sunland, Inc. voluntarily recalled the almond butter and peanut butter products that were manufactured on the same product line as Trader Joe’s Valencia Creamy Salted Peanut Butter between May 1 and September 24, 2012. On the evening of September 24, Sunland Inc. expanded their recall to include about 100 products, including peanut butter and other products made with nuts and seeds.
On October 4, Sunland Inc. expanded its ongoing recall to include all products made in the Sunland nut butter production facility between March 1, 2010 and September 24, 2012. The company added 139 products to the recall, bringing the total number of products being recalled by Sunland Inc. to 240.
The expanded recall covered all previously identified peanut butter, almond butter, cashew butter, and tahini products as well as roasted blanched peanut products made at the facility. New product categories added to the list were several varieties of flavored butters and spreads, including thai ginger butter, chocolate butter and banana butter. In addition, the expansion covered forty-nine (49) products that were within the manufacturer’s recommended shelf-life and ninety (90) products consumers may still have had in their homes which were older than the “Best-If-Used-By Date”.
On October 12, 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.
Sunland raw and roasted peanuts available to retail customers were distributed primarily under the company’s own label and were distributed primarily to produce houses and nationally to numerous large supermarket, grocery and retail chains. The products also were available for purchase on the internet.
Peanut butter and other nut and seed spreads made by Sunland Inc. were distributed nationally under several brand names via supermarket chains and on the internet.
Information on all products that were recalled as a result of this outbreak investigation is available in a searchable database of press releases related to the Sunland Inc. recall:
On November 26, 2012, in the interest of protecting public health, the U.S. Food and Drug Administration suspended the food facility registration of Sunland Inc. The fact that peanut butter made by the company has been linked to an outbreak of Salmonella Bredeney that has sickened 42 people in 20 states, coupled with Sunland’s history of violations led FDA to make the decision to suspend the company’s registration.
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.
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.
On December 21, U.S. District Judge William P. Johnson of the District of New Mexico signed a consent decree imposing requirements on Sunland Inc.to keep potentially harmful products from entering the marketplace.
Based on the requirements of the consent decree, FDA determined that adequate grounds no longer existed to continue the suspension actions vacating the suspension order and reinstating Sunland’s food facility registration. However, the company cannot process or distribute food from its peanut butter plant or peanut mill plant in Portales, N.M., until it has complied with the consent decree’s requirements to the agency’s satisfaction. Sunland must receive written authorization from the FDA prior to resuming operations at both its peanut butter and peanut mill plant.
The consent decree requires that Sunland retain an independent sanitation expert to develop a sanitation control program that the company must then implement. The requirements also include compliance with the current Good Manufacturing Practices regulations. In addition, for the peanut butter plant, the company must conduct environmental monitoring and testing to ensure that disease-causing organisms are not present in the facility or in its finished foods and must have comprehensive inspections conducted by an independent sanitation expert.
The consent decree permits Sunland to receive, hold, and distribute raw, unshelled peanuts from its storage buildings because the raw, unshelled peanuts are bound for processing facilities that include a “kill step” to eliminate Salmonella and other pathogenic bacteria.
The product information on this web page is from company recall announcements. The recall information has not been verified by the FDA, and the FDA is not responsible for its contents. The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
FDA News Release: Federal judge enters order imposing restrictions on Sunland Inc.