There is a long front page article in today's New York Times on the safety, or lack thereof, in hamburger production. The underlying message of the article is that if only industry would agree to a more vigorous testing regime hamburger would be safe.
The article draws a clear picture of a global, industrial, beef supply chain driven by relentless cost-cutting. For reasons both technical and practical, no testing regime will ever deliver meaningful improvements in safety in this structure. Attempting to test your way to food safety under these conditions is the proverbial band-aid on a gunshot wound.
Moreover, the article completely ignores the food safety implications of a beef supply chain beginning with animals raised in confined feedlot operations. Ironically, by focusing on testing and regulation rather than the root causes of the E. coli problems, this article, on the surface hostile to large agribusiness, plays into the idea that we are a few regulatory tweaks away from improving food safety, rather than considering more profound and difficult questions of reforming the entire farm-to-table system.
The FDA has updated its narrative account of the PCA crisis to focus on the recall from the Plainview, TX plant, including the following:
The Texas DSHS is currently notifying all first-level customers of PCA Texas products from January 1, 2007 forward that all products are subject to recall. FDA will audit 100 percent of those PCA customers to facilitate the removal of product from the marketplace.
There are several recall notices already posted on the FDA website, and many more press releases out on the web that haven't been posted to the FDA site.
Few have noted that the FDA field staff which is carrying out these recall audits is exactly the same staff responsible for routine inspections and other investigations. State inspectors are also contributing to the follow-up work, based on a couple of conversations I've had with field inspectors.
This is a vicious cycle -- the underfunded and overworked field staff is unable to conduct routine work in a way that might prevent a recall of this size, so the recall happens, pulling that staff for weeks on end away from routine work, so....
Meanwhile, the political classes and editorial writers yammer on and on about federal level reorganizations and a laundry list of other fairly useless "reforms."
Time for an FDA field staff surge. We can worry about rest later.
President Obama's budget proposal for 2010 includes $1 billion for the FDA to "increase and improve inspections, domestic surveillance, laboratory capacity and domestic response to prevent and control foodborne illness."
I have a dim understanding of the federal budget process, but I assume that it will be a bit before we have the opportunity to learn the details about this proposed spending. (And months and months until we see actual Congressional action.)
But I think it is interesting to compare this to the FDA's budget request for food safety for the current fiscal year, which is here.
The 2009 FDA request was $661.8 million, an increase of $42 million over the prior year. This increase would have provided almost $23 million for field activities on the food side, most of which would have gone to hire additional field inspectors.
I could be wrong, but I don't think the President is proposing taking the food safety budget from $600+ million to $1.6 billion, but from $600 million to $1 billion total.
Still, we'd be looking at over a 50% increase in the food safety budget. Moreover, if spent along the lines that the FDA has already laid out in their 2009 request, it would go a long way towards improving food safety.
I still stick to my position. The biggest problem in our food safety system is lack of funding. Compared with adequate funds, all the other regulatory and organizational "reforms" being so earnestly advocated are a side show.
Fascinating talk, and something to consider while working out how to improve food safety after the PCA scandal.
The Georgia Senate has passed a bill to require food testing and submission of positive test results to the state. If properly funded -- and this is a huge if -- I have no doubt such a plan would help improve food safety. But it is not a silver bullet.
The testing of food destroys the food. So you can never test 100% of the food and say that it is 100% safe. You have to take samples of the food (called your sampling plan), and based on the results of the test, you can infer that the food is safe. But different foods and different processes require different sampling plans. It also matters exactly what you are testing for.
Determining effective sampling plans for probably hundreds of different foods in hundreds of different settings would be massive, and I would add, highly technical task. (Unless Georgia goes to some crude one size fits all regime, or maybe S, M, L.) It is worth pointing out that a deep knowledge of statistical inference and sampling strategy design is not going to part of the skill set of the typical environmental health specialist.
The bill provides that if a company submits a testing plan as part of a food safety plan, and if the state approves it, then they can use that plan. The approvals would be a slightly less massive job. The prime benefit would be the advantage early on in getting a look at everybody's testing strategies. Some would be highly sophisticated, and could be used as models.
Before everyone jumps on the more testing bandwagon we need to be clear that monitoring a test regime of this magnitude will require a lot of staff and a lot of computer hardware and office space.
I'll also point out that the easiest thing in the world for an unscrupulous food manufacturer to do is to evade a regime like this. It is just as easy to pull your samples from a bulk package of previously tested product as it is off your line.
I'd rather see the money and effort go into boots on ground -- more, better trained inspectors and more frequent inspections.
There has been some coverage of the fact that PCA's Georgia plant had obtained a "superior" rating on an inspection by AIB, apparently required by Kellogg's. Read this fabulous post by Jim Prevor at Perishable Pundit on this topic.
When my company used to be an ingredient supplier we were required by several customers to be inspected by AIB International (then the American Institue of Baking). This was before my time, so I don't really know a lot about the effectiveness of private third-party food plant inspectors. Nevertheless, all kinds of pundits and bloggers, who know even less than I do, seem to be advocating for more extensive certification as part of the solution to improving food safety. Like many of the supposed solutions, this is no magic bullet.
My wife suggested I put some of my thoughts about the peanut recall on Daily Kos. The text of my post follows. There were a number of interesting and helpful comments, several of which I responded to. I hope to copy some of the comments and my responses over to this blog later today.
One long month in the peanut butter business from an insider:
Last month I was trying to sell peanut butter at the San Francisco Fancy Food Show when people started showing up at my booth and asking me if my peanut butter contained salmonella. This was not a good way to find out about a recall. Since we do all of our own roasting from raw peanuts, I knew our peanut butter wasn't affected by the recall. So I wasn't terribly concerned.
I then got a couple worried phone calls from our staff back at the office in Grand Rapids. Customers are calling. They want to know if our peanut butter is "safe." Safe is a hard word. Yes, our peanut butter is safe as in "he is a safe driver -- he's never had an accident, doesn't drink, drives a Volvo, doesn't speed." And we haven't had a problem in our 80 years of making peanut butter. But safe as in "100% guaranteed safe absolutely no risk under any circumstances" -- as the mother of a child with a chemotherapy-impaired immune system asked us -- no. There is no responsible food manufacturer who can say that.
Back home from the food show, I watched this recall unfold like a slow-motion train wreck. While our peanut butter wasn't affected, we needed to check our purchasing records for our retail stores. A couple of our suppliers issued recalls on some products, but nothing we had purchased. One bullet dodged. But we are still watching the FDA Recall List like a hawk.
We put a little notice up on our web site indicating that we weren't affected by the recall, and put ourselves on the primary list of unaffected products. We assured our wholesale customers that we were unaffected.
I next scheduled a series of small group meetings with all of our employees to talk about the recall, our responses, and to re-emphasize how important our sanitation and personal hygiene rules are. I am fond of saying about business problems "lighten up a bit, nobody is going to die." In the case of sanitation, that's not so.
I also told our employees that for a couple weeks every inspector in the nation was going to be tied up chasing down all the recalled products. Once that was over, we could expect the FDA to show up.
For the next two weeks I spent most of my time on line following the reporting as carefully as I could. This wasn't rubber-necking, but an attempt to figure out exactly what had happened at the PCA facility. In the case of the Peter Pan recall in 2007 the explanation given for the salmonella contamination was a roof leak. Fine. Keep the roof from leaking -- we're on it.
But now we had a second recall in two years. Had something changed in the peanut supply chain -- practices in the peanut fields, in the shelling process, in the heat resistance of salmonella? -- that meant that industry practices which had previously prevented illness were no longer effective? Was general nastiness in the PCA plant enough to explain to their problems? (Maybe, but I have my doubts.) If it is general nastiness, why was the FDA considering moving peanut butter to the "high risk"category? Political cover? Or do they share some of my questions?
On February 5th we shut down our nut roasting, confectionery, and peanut butter lines for our annual preventative maintenance period in which we really tear apart the equipment. Since we would be shut down for a couple weeks at least, I decided this was time to review all of our practices to see if we had holes in the safety net. In addition to a complete internal review, I have hired a sanitation expert from the largest food safety consulting company to come and review our practices as well.
Last Thursday (2/12) I was just finishing up a conversation along these lines and informing my senior managers of our plans when there was a knock at the conference room door. "Jeff, the FDA is here." Even though I was expecting this, I felt like I'd been called to the principal's office.
I met the inspector at the door with my production manager. The inspector showed his ID and badge (yes, they have badges, just like the police), and we went to a conference room. He explained that we were due for our annual inspection and that today was the day because his supervisor had picked us out and moved us up the list. The initial concern was that we had covered all the bases in checking to be sure we had not purchased or sold any recalled items. But in asking questions our inspector realized that we actually made peanut butter ourselves. After an hour or so of additional background questions on the company, products, distribution, and such matters, it was time to do the walk through the facility looking for Good Manufacturing Practice violations. We gave him everything he asked for, and answered his questions forthrightly.
That took another hour (it would have been longer had we been operating). The inspector left for lunch and checked with his office for additional guidance. The main issue was whether to return and take environmental swabs for testing, and whether to pull product samples for microbiological testing. Since we were shut down and hadn't run for a week, the decision was no. We will, as a courtesy, inform them of our next few peanut butter runs should they desire to inspect. We haven't received the written report of the visit yet, but I expect it will be clean, just as our last nine annual inspections have been.
A long story. What's the point? Much political energy is being put into reform proposals. But the rubber hits the road when an individual inspector walks into a particular plant. In our case, that is for 3 or 4 hours, once a year. The other 364 days it is up to me and my employees, working on food safety issues as I've tried to work through this one.
Is that a problem? In PCA's case, yes. But would an additional annual inspection have prevented it? Two more inspections? Three? Would combining USDA's food regulation authority with the FDA's have prevented this? How, exactly? Would having federal inspectors replace state inspectors help? The inspector who called on us had worked for the State of Michigan for years before moving to the FDA. Would some enhanced ability to trace food help? Only after the fact, when it is too late. HACCP plans for all food manufacturers? PCA had one. How about reporting all salmonella and other microbial tests to the FDA? How many people would it take to police and follow up on millions of tests conducted by hundreds of labs, and by companies in house?
I'm OK with all of the above, and with having my taxes raised to pay for it all. But the safety of our food is still going to depend on ordinary people struggling to do the right thing every day.
Surfing around the internet, I see several links to lists of "safe" peanut products. And we've seen food companies rush to label their peanut butter as "safe." But I think there are two different meanings to that word.
One meaning is 100% guaranteed, no risk whatsoever "safe."
The other meaning I'll illustrate with a little story. Imagine that you are going to hire somebody to drive your elderly parents and their grandchildren -- your children -- to Florida. You want a safe driver. You find a friend who is willing. You have ridden in the car with this friend many times. She has always driven very cautiously. Your friend has never had a ticket. Your friend has a very safe car which is well-maintained. Your friend doesn't drink. Your friend is unaware of any medical conditions that could cause trouble while driving. Anyway, you get the idea -- your friend is a "safe" driver.
So you ask your friend -- Will you guarantee me 100% that you won't get in an accident on the drive to Florida? Of course, the answer to that question is no.
I think most of our food meets the "safe driver" definition of safe. (Not enough, but the overwhelming majority.)
I don't think any of our food meets the 100% no risk definition. Never has. Never will.
The FDA is considering putting peanut butter in the "high risk" category. Sounds great, but what does that mean? The definition, from the FDA's Compliance Program Guidance Manual is "foods that may present hazards, which FDA believes, may present a high potential to cause harm from their consumption." That is pretty general, and I've never seen a list of formal criteria.
What foods are considered "high risk?" I've been unable to find a complete list.
For some foods considered high risk -- soft cheese, seafood, and juice -- the FDA has created detailed and specific compliance guidance. The rest of the high risk foods -- whatever they are -- are subject to heightened scrutiny but not to special regulatory rules tailored to those foods.
So, speaking as a manufacturer, I can't really say what being listed as "high risk" will mean. But I assume I'll be finding out.