May 2009

 Few would have predicted that when history is written on the first term of the Obama Administration that peanuts and pistachios would play such prominent roles.   Those unlikely products, however, will be used by historians to demonstrate the bad old ways versus the new U.S. Food & Drug Administration (FDA).

Maybe because the new President himself came from the streets of Chicago, he went to the front lines of the country’s public health challenge to select Dr. Margaret Hamburg as FDA Commissioner and Dr. Joshua Sharfstein, as her deputy.   Dr. Hamburg, an expert in biological defense and disease control, was during the 1990s the youngest person in history to serve as New York City’s health commissioner.  Dr. Sharfstein, a pediatrician, came to FDA directly from heading up the Baltimore Health Department.

It is really hard to overstate how unusual it is to have two top FDA officials from the gritty streets of big cities.   Almost all previous FDA Commissioners come from academic and research backgrounds.  You can go through each biography of past FDA Commissioners here. 

Few had any in-the-streets experience.   LBJ’s last commissioner, Dr. James Goddard, came out of the Public Health Service at a time when federal doctors wore uniforms and saw patients.   And Nixon’s appointee, Dr. Herbert Lay, Jr., was known for his service as an epidemiologist for our troops in Korea and Vietnam.

But that’s about it.   FDA Commissioners have not been folks who got their hands dirty, knocking down the TB rate in the Big Apple as Dr. Hamburg did or taking on the dangers of over-the-counter cold and cough medicines for children under age 2 as Dr. Sharfstein did.  The typical FDA honcho creates process, not results.

So when Sharfstein took over FDA, while waiting for Hamburg to clear the Senate, it really should have come as no surprise that he opted to recall Salmonella-contaminated pistachios before anyone got sick.

The FDA has completed its inspection of Salmonella contamination in pistachios and pistachio products at Setton Pistachio of Terra Bella, Inc., Terra Bella, Calif., and presented a 483 Inspection Report to the firm.Continue Reading Peanuts and Pistachios & The New Team In Charge Of FDA

Toxic RefrigeratorA person working in an AT&T building in San Jose, California, decided to clean out an office refrigerator that had apparently been unplugged for some time on Tuesday.  Unfortunately, the combination of smells from rotten food and disinfectant was overpowering, and another building employee called 911 after smelling the fumes.  Seven people were sent to the…

Officals in Montgomery County, Pennsylvania have anounced that 3 individuals have been confirmed with cryptosporidium.    While public swimming pools are common source of cryptosporidium outbreaks, there is reportedly no evidence of such a connection here.   None of the ill individuals had public pool exposures.  Officials are still investigating to possible source of the cluster of…

As reported by the Wall Street Journal’s Jane Zhang,  states frustrated by the slow pace of national food safety reform have begun to take matters into their own hands.  Georgia was hit hard by the recent outbreak of Salmonella in peanut butter and peanut products;  as the leading producer of peanuts in the US…

Good Lord, where do I start?  Well, to begin with, thank you to Mr. Orwig (picture left), Caudill Seed, and Jim Prevor, aka "the Perishable Pundit" (the latter thank you being entirely without my tongue in my cheek–I really do enjoy Jim’s weekly emails) for a wealth of extremely valuable information.  What I’m referring to here is an interview that the Pundit had with Lyle Orwig, spokesman for Caudill Seed, who is now embroiled, despite any remonstrances to the contrary, in a public health nightmare–i.e. national Salmonella outbreak–linked to its alfalfa sprout seeds.  Read the interview here. 

There are lots of things to talk about, legal and otherwise, after reading the interview.  Much of it will have to wait for official discovery and trial, but I do want to highlight just a couple of things:

Pundit:  FDA says the preliminary epidemiology ties the alfalfa salmonella outbreak to Caudill seeds. What can you tell us?

Orwig:  The seeds have been implicated but there is no proof. While the seeds are said to be epidemiologically linked, FDA hasn’t been able to conclusively tie the source of the salmonella in the sprouts back to where it actually occurred. FDA would need an exact fingerprint serotype match, but it has no confirmed test.

From the seed company perspective, we encourage all sprouters to follow FDA food safety guidance. Back in ’99, they did all that work to establish best practices. If the seeds are treated with recommended soaking chemical and the sprouters do that and test and hold, we wouldn’t be talking about this problem now. Not everyone tests and holds.
 

The voice of reason (that’s debatable):  I don’t mean to tell anybody how to do their job.  That is for bosses, and I’m not there yet.  Mr. Orwig is a public relations guy who works for a prominent PR firm called Charleston Orwig.  Here is my one bit of advice for Mr. Orwig:  you do not do your business or, more importantly, your client’s business any good by trying to obscure the issue.  I don’t know, maybe it’s a legitimate PR tactic to deny and then hedge, but the reality is that Caudill has been linked to a massive salmonella outbreak.  How do I know?  What do 228 people across the country who are sick with Salmonella Saintpaul have in common?  You guessed it.  I don’t need a genetically matched sample from the grounds or product at Caudill Seed to convince a jury of that. 

Pundit:

Are food safety measures conducted at the seed level? Does the seed company hold some responsibility here? On your website, it says all of the alfalfa sprouting seed provided by Caudill has been tested for germination, purity and absence of salmonella and E coli. How does that work?

Orwig:

We sell a raw agricultural product. What that means is that the alfalfa seed is either put into the ground to grow, or the sprouter will use it to produce edible product. It can be the same seed. Part of the seed industry law, in and of itself, is that when we sell, there’s a seed tag that shows what the germination is of that bag of seed, as well as the purity and process it has gone through. This is part of the federal law we follow that has to go on every bag we send out. When we buy seed, it’s sorted, tested and bagged and when it’s bagged and the tag goes on it, we’ve followed our legal duty. Then it’s the sprouter’s responsibility.
 

The voice of reason (highly debatable):  Mr. Orwig gives yet another example of the attitude that, in my view, is responsible for many, many of the foodborne illnesses that occur in this country every year.  Essentially what he’s saying is, "our responsibility for food safety begins when the seeds come through our doors, and our responsibility ends when the seeds leave."  Is bullshit too strong a word here?  I don’t care about FDA guidance, if any, on this issue.  Caudill, you and every other food manufacturer in the country has a continuing obligation to protect the people you profit from–i.e. consumers–before you receive your product and after you sell it.  This means, at a minimum, knowing the companies you do business with, and knowing all intended uses.  It also means TAKING ADEQUATE STEPS TO PROTECT THE CONSUMERS WHEN YOU KNOW, OR HAVE REASON TO KNOW, THAT A PROBLEM EXISTS.  See my post yesterday about recalls and market withdrawals.  I guess the good thing in this kind of attitude is that it will keep us in business.  I don’t know how this helps consumers of your products though.Continue Reading Interview with Lyle Orwig, Spokesman for Caudill Seed