Category: FDA

FDA Flexes Muscles To Achieve Kasel Pet Treat Recall

The extensive ‘voluntary’ pet treat recall announced on February 19th by Kasel Associated Industries (Denver, CO) was triggered by FDA’s threat to invoke its new mandatory recall authority, according to Siobhan DeLancey, spokesperson for FDA’s Office of Foods and Veterinary Medicine.

Earlier today, DeLancey informed eFoodAlert by email that Kasel chose to voluntarily recall its products upon receipt of a “last chance” letter from FDA (formally, a Prehearing Order to Cease Distribution and Give Notice, also referred to as a 423(a) letter). This is the first time that FDA has initiated mandatory recall proceedings under the authority granted to it by the Food Safety Modernization Act.

FDA inspected Kasel’s manufacturing facility during a 10-day period beginning September 19 2012, after the Colorado Department of Agriculture found Salmonella in a finished product sample of Boots & Barkley 6-count 5-inch American Beef Bully Sticks. Kasel recalled four lots of the product on September 21st (Lots #BESTBY20APR2014DEN, BESTBY01JUN2014DEN, BESTBY23JUN2014DEN, and BESTBY23SEP2014DEN). On October 2nd, the company recalled Nature’s Deli Chicken Jerky Dog Treats (2.5 lb; Lot #BEST BY 091913 DEN) after FDA found Salmonella in a sample of this lot code. Additional testing carried out by Colorado prompted a third recall on October 17th, this time of Boots & Barkley Roasted American Pig Ears and Boots & Barkley American Variety Pack Dog Treats (Lot #BESTBY 13SEP2014DEN for both products). Colorado found Salmonella in another retail sample of Nature’s Deli Chicken Jerky Dog Treats (Lot #BESTBY061913DEN) in November 2012; however, Kasel refused to initiate another recall.

The September 2012 inspection carried out by FDA revealed several sanitary issues, including live insects and evidence of rodent activity in the manufacturing facility, DeLancey said. Furthermore, FDA recovered Salmonella from all of the finished product samples collected during its inspection, as well as from 1 out of 2 in-process bulk product samples and 48 of 87 environmental swab samples. Some of the Salmonella-positive swab samples were taken from food contact surfaces. In all, FDA found 14 different strains of Salmonella: Anatum,  Mbandaka,  Senftenberg,  Typhimurium, Agona,  Muenchen, Irumu,  Tennessee, Montevideo, Infantis, Muenster, Derby, O rough;d;e,n,x,  and London. Isolates recovered from products made on June 19th matched those from September 19th, indicating an ongoing contamination issue.

FDA carried out a follow-up inspection on February 14, 2013, including additional finished product and environmental swab sampling. Results of those samples are still pending; however, FDA noted that the company had taken several corrective measures.

I found it strange that the latest recall covered only the period from April 20, 2012 through September 19, 2012. DeLancey explained that this was the time frame during which positive results were collected. If FDA finds additional Salmonella-positive samples as a result of its follow-up inspection, I would expect either an expansion of the most recent recall or – in the event that Kasel proves recalcitrant – another FDA-issued warning.

FDA has received a “small number” of complaints from pet owners whose dogs became ill after being exposed to the recalled treats. No human illnesses have been reported yet.

eFoodAlert Advice to Consumers

  • Check your supply of pet treats against the products listed in the most recent recall notice. Discard any that are mentioned on the list. If you are not sure of the origin or lot code of the treat, discard it.
  • If your dog develops symptoms of a Salmonella infection (typically diarrhea or vomiting) after consuming a Kasel-manufactured treat, seek veterinary attention; also, report the illness to FDA.
  • If you or a family member develop symptoms of a Salmonella infection after handling a Kasel-manufactured pet treat – or a sick pet – seek medical attention, and mention the possible link to the pet treat.
  • Always wash your hands immediately after handling any pet food or pet treat, especially one of the affected brands listed in the recall notice.

If you believe that your pet or a member of your household has become ill as a result of exposure to one of the brands of pet treat mentioned in the recall notice, please post a comment.

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?

Guest Blog: Going Public The FDA Way

The following Guest Blog first appeared on barfblog.com, and is reproduced here with the kind permission of its author, Doug Powell.

Going Public: there may be some rules but FDA says they’re a secret

by Dr. Douglas Powell

The same agencies that tout a science-based approach to foodborne illness aren’t so good at one of the 3 legs of the risk analysis stool – risk communication.

It gets lots of pandering, but almost all government agencies and industry groups, regardless of geography, are really bad at risk communication when performance is stacked up against what has been proven to work (not very much).

When to go public about health warnings – like potential outbreaks of foodborne disease – remains contentious. And no one is willing to come clean about it and say, this is when we go public and why. Or at least write it down. Bureaucrat 101 – write it down, have to do it; so don’t write it down.

I understand the flexibility public health types require to do their jobs effectively, but much of the public outrage surrounding various outbreaks – salmonella in tomatoes/jalapenos, 2008, listeria in Maple Leaf deli meats, 2008, the various leafy green recalls and outbreaks of 2010, 2011, 2012, the 1996 outbreak of cyclospora linked to Guatemalan raspberries, and the delay in clamping down on Iowa eggs – can be traced to screw ups in going public.

It’s long been a tenet of risk communication that it is better to go early with public information rather than later. People can handle all kinds of information, especially when they are informed in an honest and forthright manner.

So it’s of no surprise that the U.S. Government Accountability Office (GAO) couldn’t find anyone within the Food and Drug Administration (FDA) to say, this is how we decide when to go public.

“FDA has interim internal procedures describing the steps it will take to order a food recall, but these procedures have not been made public, and the agency has not provided information on when they will be. Federal internal control standards call for federal agencies to clearly document
policies, procedures, techniques, and mechanisms for implementing management directives and to make that documentation readily available for examination.”

“Similarly, FDA officials told us that they have not decided whether they will issue regulations or industry guidance to clarify for the public FDA’s procedures for ordering food recalls and that FSMA has no requirement to do so. Federal internal control standards direct federal agencies to
ensure adequate means of communicating with and obtaining information from external stakeholders who may have a significant impact on the agency achieving its goals.

“About a week-and-a-half before our closing meeting, FDA officials provided us interim internal procedures for ordering recalls of food. These interim procedures include detailed information on such topics as which officials are to be involved in an ordered food recall decision and what methods and timelines FDA officials will use to communicate with companies involved in such a recall. The interim procedures also state that FDA is to incorporate procedures into the
agency’s publicly available Regulatory Procedures Manual and other FDA documents. FDA officials have not, however, provided timelines on when they expect to make procedures publicly available.”

And it goes on like that for 61 pages.

GAO recommends, among other things, that FDA issue regulations or industry guidance to clarify its ordered food recall process and implement recommendations from others to address FDA communication challenges in advising the public about food recalls and outbreaks. The agency neither agreed nor disagreed with GAO’s recommendations but cited ongoing agency actions that are to address most recommendations.

To strengthen FDA’s process for ordering recalls, the Secretary of Health and Human Services should direct the Commissioner of FDA to document FDA’s process for ordering food recalls in regulations or industry guidance to include information on how the agency will weigh evidence on whether a recall is necessary.

To address FDA’s communication challenges in advising the public about food recalls and outbreaks, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement recommendations from the Institute of Medicine and National Research Council to develop, in conjunction with other federal agencies, a coordinated plan for crisis communications.

To address FDA’s communication challenges in advising the public about food recalls and outbreaks, the Secretary of Health and Human Services should direct the Commissioner of FDA to implement recommendations from FDA’s risk communication committee to develop a policy for communications during emerging events.

The full report is available at http://www.gao.gov/products/GAO-12-589.

About the author: Dr. Douglas Powell is a professor of food safety at Kansas State University and the publisher of barfblog.com. Powell is passionate about food, has five daughters, and is an OK goaltender in pickup hockey.