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Advocates Praise FDA’s Sunland Suspension, Urge Action on FSMA

Prominent food safety advocates praised the U.S. Food and Drug Administration for using its newly granted authority Monday to suspend the registration of Sunland Inc., the nation’s largest organic peanut butter producer and the company tied to a Salmonella outbreak that has sickened at least 41 people in 20 states.

At the same time, the FDA and the Obama Administration received criticism from those same sources for delays in finalizing languishing portions of the Food Safety Modernization Act (FSMA) since its passing almost two years ago.

On Tuesday, politicians and consumer interest groups including Congresswoman Rosa DeLauro (D-CT), Pew Charitable Trust’s Food Safety Campaign Director Sandra Eskin and the Center for Science in the Public Interest expressed their approval of FDA for using its suspension authority for the first time since the passing of FSMA in January 2011.

“Congress gave the FDA this authority in the Food Safety Modernization Act so it could protect the public from unsafe food being produced in facilities like this and I am pleased to see them act,” DeLauro wrote in a statement. “Americans should be able to buy a jar of peanut butter – or anything else – without worrying that it will sicken them or their children.”

With its FDA registration suspended, Sunland will not be allowed to sell its products anywhere in the U.S., including in its home state of New Mexico.

Speaking with Food Safety News, Eskin also praised FDA’s move, but added that preventative rules in FSMA that are stuck awaiting implementation could have allowed the FDA to suspend Sunland before any illnesses occurred.

“This is reactive. More than 40 people have gotten sick from eating a contaminated product,” Eskin said. “In light of that the FDA has shut them down, and that’s really really good, but it would be excellent if we could have shut them down based on prevention-based food safety measures.”

Before FSMA, the FDA required a court order to stop companies from selling food, Eskin said. Acquiring one took time, making it a largely ineffective approach to preventing outbreaks.

Having halted its own operations after expanding its voluntary recall in early October, the company planned to restart shelling peanuts on November 26 — a plan it outlined in a letter to the FDA on November 20. The FDA issued the suspension on the 26th, a move that Sunland called unexpected and disappointing in a statement on its website Tuesday.

“During the last two months Sunland has been working with experts as well as with FDA, analyzing data, and developing and implementing proposed corrective actions in order to be in a position to reopen first the shelling plant and then the peanut butter plant.  These plans were submitted to FDA in our response to the inspection observations,” the statement read.

“Sunland expected that any agency concerns with its plans would be part of the ongoing dialogue with the agency,” the statement continued.

The company added that it was continuing to work with the FDA to accomplish whatever necessary to safely begin operations in its peanut mill as soon as possible.

© Food Safety News
  • KennethKendrick

    I do believe that this is an example of why we do not the rest of the FSMA to be pushed through. This looks like, peanut corp. PCA and Sunland We have never had Salmonella : FDA says here is proof you did,  PCA and Sunland  well we did but we never shipped it. FDA here is proof you shipped it; PCA and Sunland; Well yeah, but we never knowingly shipped it. You  have to pick one of the 3 answers! I still believe they will go bankrupt, let the insurance pay the Victims. What we need to know, is which people knew what, and when did they they know it, and why did no one say or do anything?

  • These agencies need to have the power to force  recalls and close plants immediately and without warning.The health and lives of consumers must come before these companies/business.

  • MrMcFritters

    Eskin raises the key point — would the FDA have been willing or able to shut down Sunland in 2009 if the FSMA had been implemented?  I wonder.  My understanding from a senior FDA official is that once the FSMA is in place that most inspections will be extensive paper reviews of the documents and records in the HAACP plan.  Having had experience with health care accreditation and ISO certifications in automotive I see no reason to believe that paper reviews will be an effective replacement for inspectors with deep substantive knowledge of what they are looking at.  The FDA lacks that now in many if not most areas, and shifting under-trained and over-worked investigators from the pre-FSMA regime to the FSMA regime seems unlikely to me to make a difference.

    Food safety activists have treated our outbreak troubles as a regulatory problem when I think the problem is the same one faced by financial regulators.  They are attempting to regulate huge and powerful industries with better funding, deeper expertise, and more good lawyers (mostly former FDA lawyers, I’ll add).  In this budget environment, there is no reason to believe the FDA won’t continue to be reactive, and perhaps will start reacting by making examples out of folks.  Short-term that may get the press and some advocates off their back, but long-term it will hurt.

  • MrMcFritters

    I don’t think that is an accurate description of what either PCA or Sunland said, but let’s look at Sunland.  They tested composite samples of full day runs of peanut butter.  That is, they took multiple samples, combined them, and cultured.  When they got positive results on the composite, they then employed some sort of a procedure to test individual (non-composite) samples and attempt to narrow down the problem product to less than full day run amounts.

    That is a highly suspect and fraught exercise (and we know in at least one case it didn’t work).  However, depending on certain assumptions and other data that they may have had available on production runs, it could be done in theory, and it isn’t impossible that they had a microbiologist sign off on it (hence, no “knowing” violation).

    In any event  the FDA is correct to condemn the attempt to salvage partial lots of product.  As troubling to my way of thinking is what Sunland did after the positive tests began in 2009 by way of root cause analysis to learn what was causing episodic positive tests, and what, if anything, did they change to attempt to prevent recurrance?   

    The good news under the FSMA is that going forward production problems like this must be documented and the steps to prevent problems from recurring documented as well.  Perhaps that will help, but like the rest of the FSMA, it is no magic bullet so long as the agency remains without the resources to do its job properly.