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Letter From The Editor: FDA “Hereby Suspends”

Opinion

It was one week short of 700 days when the U.S. Food and Drug Administration (FDA) dropped the hammer on the economy of Portales, NM.

It was that long between Jan. 11, 2011, the day President Obama signed the Food Safety Modernization Act (FSMA) into law after it had been passed by large bipartisan majorities in the 110th Congress, and Nov. 26, 2012, just last Monday, when FDA Commissioner Margaret A. Hamburg “suspended” Sunland Inc.’s food facility registration in the U.S.

Almost 700 days is long enough to put almost all of us to sleep.

We knew about all those new powers the FSMA was making available to FDA, but we were all living under the false assumption that all of the new substantive powers were being held up in that regulatory snarl at the White House.

In addition to being able to “hereby suspend” a food manufacturer’s registration, FDA can now order a recall and deny entry to the U.S. of imported food and beverages if inspection is refused along with a host of other powers, some that require regulations be in place and obviously, some that don’t.

At America’s largest and most troubled organic peanut butter plant in Portales, the hammer Hamburg dropped fell not only on Sunland Inc., but also on all the area’s Valencia peanut growers, a workforce of 150, and the entire Portales community. Millions of pounds of peanuts, most already in Sunland’s storage barns, await processing before any payment will be made to those farmers.

Of course the other side of this tragedy finds 42 people in 20 states taken ill with the Salmonella strain connected to Sunland’s facility and an inspection history of problems dating back several years. The multistate Salmonella outbreak, first traced to a Sunland-manufactured Trader Joe’s brand of organic Valencia peanut butter, led to the recall of 240 brands of nut products and the shutdown of the plant two months ago.

More disturbing is possibility that the inspection history suggests, which is that Sunland knowingly shipped contaminated peanut products from the Portales plant at times during the past three years or so. The company flatly denies that.

Sunland planned to re-open on Tuesday to begin shelling this year’s peanuts, but then for the first time FDA used that new FSMA power to suspend without judicial review a food manufacturer’s operations in the U.S.

The action, explained in a 5-page letter signed by Hamburg, was just one of those surprises for the broader food safety community—something new and unexpected in a regulatory field that usually revolves around the routine.

For Portales, especially for those laid off workers and peanut growers waiting for those crop payments, it’s a different story. It’s the boot of a distant federal government coming down on the small town, its people and future.

Sunland’s side of the story is that it responded to the FDA inspection findings issued on Oct. 29 with what it believes was a solid plan for corrective action to prevent further contamination. It apparently had help drafting that plan from the respected  Michael Doyle, director of the Center for Food Safety at the University of Georgia.

Without telling Sunland, FDA in Denver and Washington D.C. decided the planned corrective actions were not enough, and the agency instead went to work writing the Hamburg letter. Doyle told the Huffington Post that FDA is using Sunland to “send a message’ to small and mid-sized food plants that its time to step-it-up to higher food safety levels.

Yes, FDA does have that bag of regulatory authorities still hung up, awaiting the green light from the Executive Office of Management and Budget (OMB), a White House agency, and the food industry probably did need a reminder about those FSMA powers being the new reality.

For months, the White House spin machine has said OMB is serious about food safety and seriously working on the regulations that FDA’s Michael Taylor, the assistant Commissioner for Food, sent over many moons ago to 1600 Pennsylvania Avenue. In fact, we strongly suspect, OMB was ordered not to work on them until the election was over. In Washington D.C., that would hardly be new.

So the Hamburg letter may signal other FSMA actions are actually getting underway.

But, as practiced this first time, it may turn out to be a strange way to do business.  There does not appear to be any evidence that prior to the outbreak anything was done to signal FDA was serious about correcting the problems at Sunland.

No velvet gloves were used before the outbreak, and only the hammer afterwards.

FDA, it seems, does not send in a team of fixers to help, but instead occasionally drops by a food plant to point out problems. With FSMA being implemented against an economic reality that makes a lot of people feel uneasy, FDA needs to learn how to signal its seriousness a little earlier in the process or this could get ugly.

Portales will survive this because it seems Sunland, according to its spokesman, is going to invest in plant make-over it probably needed for years and will pay FDA’s inspection charges.

In the meantime, it can’t shell those peanuts it planned to start on last Tuesday, or in all likelihood make any payments to those growers who won’t be spending as money in town for this  Christmas as they otherwise would.

That’s too bad.

Yes, dropping that hammer is an effective way of sending a message to all parties.  But, if FDA is to use FSMA to develop a truly effective regulatory system, it is going to need to learn some some new skills involving tact and communication. That is also what being proactive is all about. This looks too much like adding new powers to the same old reactive system.

FDA inspections from 2009 to 2012 were finding problems at the Sunland plant, but nothing ever happened until people started getting sick from eating pricy peanut butter with fancy labels. That’s the fact.   When added to what FDA knew had happened only 100 miles away at Plainview, TX, where Peanut Corporation of American had failed to deal with Salmonella contamination that ended up killing nine people across the country, this  timeline does not say much for the agency or Sunland.

Americans want a food safety system where food-makers and the government both step up to their responsibilities. This was not it.

Luckily, this time body bags did not become part of the story.

© Food Safety News