Studying the FDA’s Observations at PCA, #10
Observation #10 -- Finally!
Roaches! Yikes. I lived in the South for many years. Chapel Hill and Carrboro, North Carolina. Washington, D.C. Charlottesville, Virginia. And in New Orleans. Being of Dutch descent and raised in a family of fanatical cleaners, I never adjusted to the roaches. There are roaches everywhere in Dixie. When our kids were small, messy eaters we once had roaches in our SUV.
This is not to defend PCA, but to keep roaches out of a South Georgia peanut plant it would have to be sealed as tight as drum. If the FDA's reports and press accounts are correct, the PCA plant was not.
Pest control is a huge deal in the peanut business, because everything that crawls, flies, and walks seems to love to eat peanuts. It is a matter of endless vigilance.
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
Studying the FDA’s Observations at PCA, #9
Obeservation #9 covers several basic cleaning and sanitation issues. The washroom sounds icky, that's for sure. I confess that the FDA would have said the same thing about our ingredient feed area back when we were in the industrial market -- it was impossible to keep clean.
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.
Studying the FDA’s Observations at PCA, #8
Observation #8 is that a sink was used both for cleaning hands and cleaning mops. That is nasty.
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.
Studying the FDA’s Observations at PCA, #7
I'm working my way through the FDA's report on its inspections of the PCA facility. The agency made 10 observations, this post deals with #7.
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 #7 notes that the building does not have positive air pressure in the production area. The idea here is that if the production area has postive air pressure, then when a door is opened to a warehouse, raw material storage, the outside, etc., air will flow out. If air flows in, there is the risk the air flow will carry in something nasty.
For a typical high volume peanut roasting operation, this is a problem, because the large roasters consume large volumes of air -- they have huge exhaust fans on them to take away smoke and cool the peanuts. To create positive air pressure in a roasting area would require a huge air make up unit to replace the air the roaster was exhausting out. The make up unit would use outside air, which, it seems to me, carries the potential for nasties as well. Unless this must be filtered in some way. This is not a simple fix.
PCA's problem, however, appears to have been more fundamental -- their production area was not behind a wall at all. Perhaps is this allowed by the Georgia Dep't of Ag. -- in Michigan, it is absolutely forbidden. All receiving and warehouse areas must be physically separated from production areas.
Studying the FDA’s Observations at PCA, #6
Observation #6 addresses two everyday health inspection matters. You have to be able to properly clean and sanitize food contact surfaces and you have to keep stuff covered up as much as you can.
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.
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.