Studying the FDA’s Observations at PCA, #5
Halfway there. This is number 5 of 10 FDA "obersvations." The FDA has posted the report on its inspections of the PCA facility on the FDA website, here. As PCA has noted on its website, the FDA's findings are not final, and PCA will have the opportunity to respond.
Observation #5 deals with leaks around skylights and air conditioning units. Anytime one cuts a hole in the roof of an industrial building for skylights, air conditioning, exhaust, roof access -- you name it -- you risk a leak. Enough holes in your roof, and a leak will happen, regardless of your vigilance in inspection and caulking. In fact, even with no holes in your roof, the typical steel pre-engineered building will leak. This is not to excuse PCA, especially if press accounts are accurate indicating that they had ongoing active leaks. The issue is not leaks, but whether you fix them right away and make sure that no product is affected.
Studying the FDA’s Observations at PCA, #4
The FDA has posted the report on its inspections of the PCA facility on the FDA website, here. As PCA has noted on its website, the FDA's findings are not final, and PCA will have the opportunity to respond.
Observation #4 addresses a basic tenant of food safety: keep finished product and raw materials apart. More interesting are the reports of positive environmental swabs for salmonella. A bad sign which indicates real problems. We'd flip out if we ever had a positive swab.
Studying the FDA’s Observations at PCA, #3
The FDA has posted the report on its inspections of the PCA facility on the FDA website, here. As PCA has noted on its website, the FDA's findings are not final, and PCA will have the opportunity to respond.
Observation #3 sates that PCA recognized the roasting step as a "control point" for salmonella. This indicates that PCA did in fact have a HACCP plan in effect, which is consistent with their ratings from AIB. (See also PCA's statement on their AIB inspections.)
More interesting is the FDA's assertion that the effectiveness of this control point had not been proven for PCA's specific roaster. Peanuts are typically roasted for 20-30 minutes at temperatures of 275 degrees F or more, which is enough to effectively sterilize them. And though PCA could show records indicating that the nuts had in fact been roasted for that amount of time at such temperatures, this was not enough. They had to show that these times and temperatures actually would produce control of salmonella. Which means that they had to do an experiment in which they innoculate nuts with salmonella, put them in little mesh bags, run them through the roaster, and then test them. This is consistent with the position the FDA took with respect to almond pasteurization after the last almond recall.
Studying the FDA’s Observations at PCA, #2
The FDA has posted the report on its inspections of the PCA facility on the FDA website, here. As PCA has noted on its website, the FDA's findings are not final, and PCA will have the opportunity to respond.
Observation #2 is that certain production lines were not cleaned after positive salmonella tests on product produced on those lines.
If this observation holds up, this is bad.
Studying the FDA’s Observations at PCA
The FDA has posted the report on its inspections of the PCA facility on the FDA website, here. I'm hoping to have time this week to work through the FDA's comments one at a time and see what we can learn. As PCA has noted on its website, the FDA's findings are not final, and PCA will have the opportunity to respond.
"Observation 1" covers testing and re-testing of peanut paste, peanut butter, and peanuts for salmonella. The allegations differ a bit, but most involve instances in which PCA received positive salmonella tests on certain lots of product which subsequently re-tested negative and then were shipped. This practice is generally described as "lab-shopping," but it is difficult to tell exactly what is going on here.
I can think of four different scenarios, each troubling in its own way, that might allow for a negative test to be generated after a positive test on a given lot of product.
First, however, we need a little background on testing. When testing a given "lot" of peanut products you can't test every bit of product. You have to pull a sample according to a strategy that will give you a representative sample of the full lot. Rather than do the statistical analysis necessary to work out a sampling strategy, most manufacturers follow the plan that the FDA would use in the case of an investigation. (You can find that plan here.) After the samples are pulled and sent to the lab, the lab combines them and then takes a sub-sample from which it attempts to culture salmonella.
So, how can you get a positive and a negative test on the same product?
One possibility is that certain labs are corrupt and that a negative test can be bought. I have seen no evidence that this is the case here.
Another possibility is that a lab could re-test the same sample and get a negative result. That raises a difficult question. Is there a false positive problem in salmonella testing such that poor handling of samples or lab procedures regularly generates false positive tests? Or is there a false negative problem, in which a sample with salmonella in it could test negative? Or both?
A third possibility is that the manufacturer could pull a new sample before re-testing, and hope for a negative outcome. Here, it seems that the manufacturer would be banking on getting what amounts to a false negative on a given lot based on a second sample (though maybe there is a false positive problem in salmonella testing).
The troubling thing about scenarios two and three is that if there is a serious "false negative" problem in salmonella testing, then PCA (and other manufacturers) will be shipping product in good faith that is in fact positive for microbiological contamination. In any testing scenario relying on sampling there is always the possibility of false negatives. The question is how likely is this? I'm not enough of a statistician to say. It is worth noting, however, that PCA has recalled all the product from the Georgia plant, including product which, I presume, passed micro testing with flying colors.
The fourth scenario is that a manufacturer could submit a false sample if the re-test is performed on a new sample from the lot. The FDA report did not suggest this was a problem in this case, but it would be easy to do.
The bottom line: testing by itself is not 100% reliable in preventing manufacturers from shipping bad product. Never has been, never will be.
Cost Cutting Run Wild
Our company left the industrial peanut butter and granulated peanut business in 1994. Up until then, we competed in the same markets as the Peanut Corporation of America. Thirty years of relentless consolidation on the part of retailers (and a corresponding increase in their bargaining power) brought powerful cost-cutting pressure on grocery suppliers and on their ingredient suppliers in turn. Price became the only consideration when selecting suppliers. Decades-long supplier relationships were disrupted. Lip service, at best, was paid to issues of quality. This was a game my father choose not to play.
Combine ruthless cost cutting across the supply chain with cuts in government's regulatory capacity and the outcome is predictable. Food safety has to be paid for. It can be in the grocery bill or in the tax bill. But it has to be someplace.
“Gaping Loophole” in federal food regs?
At hearings yesterday, Senator Harkin described the lack of a requirement to report salmonella findings to the FDA as a "gaping loophole." Fair enough. But at current funding levels, who at the FDA is going to follow up on all this data?
PCA Recall, cont.
I watched the brief opening statement of former FDA official Mr. William Hubbard today. He emphasized the funding issue, though he called it "capacity." When he was at the FDA there were 70,000 registered food establishments and that the FDA conducted 35,000 annual inspections. Today there are 150,000 establishments and 7,000 annual inspections. Those inspections are concentrated on the 6,000 "high risk" establishments.
The problem is clear, but it is also worse than these numbers indicate. First, the FDA inspections don't just cover food safety. They cover labeling, including nutrition labeling, and some other matters, depending on the product. These issues can be complex and time-consuming. Second, many of these inspections are conducted by state officials under contract in may states. In Michigan, our inspectors have been excellent. Perhaps they aren't as good in other states. In any case, there will be inconsistency between states.
Hubbard's second point is that the prevention regime used for USDA facilities (such as much higher risk meat plants) should be extended to food facilities. That is sensible, but has a drawback I'll come back to in another post.
His third point was that FDA's recall authority needs to be enhanced. I still need to be convinced.
But all things considered, an excellent starting point for reform.
The Peanut Corporation of America Recall
As an owner of a company that makes peanut butter, this hardly seems the opportune time to begin blogging. On the other hand, having worked with public official officials for nine years before entering the business world, I can see this crisis from both sides. Three thoughts, doubtless to be revised as more information comes forward:
First, all of our public health system, including food safety, is chronically underfunded and understaffed at both the state and federal level. This has been true for decades. Money for inspectors and ongoing training should be the top priority moving forward.
Second, there are voices calling for the creation of a new food agency combining USDA and FDA functions. I have yet to see evidence that this contributed to the current situation or would improve things going forward. From what I've seen, government improvement re-organizations rarely fix much of anything, but they are excellent political cover if you have no intention of coming forward with money.
Third, there seems to be a lot of energy for enhancing the FDA's power to order recalls. I'd tread cautiously here. In the PCA case, it may come out that action on the recall was slowed because of a lack of cooperation on PCA's part. Certainly King Nut's and Kellogg's reactions in this case were more responsible that PCA's. But I think in most cases the food supply chain moves with urgency to determine which products are subject to recall. That can be a bit of puzzle in many cases while receiving records are matched to manufacturing records to shipping records. I'm familiar with one situation in which a few hours delay and some careful research turned a potentially large recall into a minor issue.