Skip to comments.A Fight Worth Having
Posted on 03/20/2017 6:11:59 PM PDT by Beave Meister
One day in late spring in the early days of the George W. Bush administration, FDA inspectors visited the headquarters of Sargento cheese in Plymouth, Wisconsina routine visit as part of the federal government's efforts to ensure the safety of the food we eat. The inspectors took samples of cheese to test for bacteria. Sargento conducted tests on cheese from the same lot. A week later, the results from both sets of tests were inthe cheese was bacteria-free. Sargento, having gotten the all-clear from the government, shipped the cheese to stores across the country.
Two months later, however, the FDA called back. There had been a mistake. A subsequent test had found traces of listeriabacteria that can be fatal if ingested by people with immunodeficiencies. Sargento retested their samples. The Wisconsin Department of Agriculture conducted an independent test. The FDA retested, too. The results of the testing confirmed the earlier teststhe cheese was bacteria-free and fine to eat.
But the FDA has a "zero tolerance" policy on listeria and formally recommended that Sargento recall the cheese. Sargento pushed back on the decision, pointing out that multiple testsinternal and governmental, taken before and after the test that found listeriahad found the cheese bacteria-free. The FDA then made the kind of demand that only the government can make: Either you issue a "voluntary" recall or we will order you to do it.
(Excerpt) Read more at weeklystandard.com ...
The government has been literally ruining peoples lives for decades. It gets worse by the day. I don’t expect it to end.
In a sane world, the FDA would have been required to make the Cheese maker “whole”.
Liberals have never seen an activity that they didn’t want to control.
It is possible that Sargento has had a history of contamination problems in this area.
I am sure Steve Hayes would be the first to squawk if he was doubled over shitting his pants and puking his guts after eating a bad taco with this cheese on it.
It is possible, but do you know something or just speculating? If you do, I wouldn’t mind hearing of it.
This article is a perfectly legitimate criticism of overreach in government.
I would personally speculate that it is just as possible that the incompetent FDA contaminated their own samples.
Most consumer goods firms who make food products carry business insurance for events such as this, much like medical doctors carry mal-practice insurance. It is a routine cost of doing business.
I believe that there should be a degree of governmental oversight of food industries, that provides us with protection so we don’t have the problems here that the Chinese have with their foods.
That said, the fight against overregulation of industry is a fight worth having, which is something Donald Trump appears to be in favor of fighting.
I think it is overdue.
I don't have the time to do look backs. Suffice it to say that I do know Listeria contamination in cheese is a common problem as a review of product recalls in just the last 60 days attests for several firms, including Sargento.
I count 14 such recalls.
I don’t doubt it is a problem, but the specifics of this particular case with independent samples and company samples make me want to give the benefit of the doubt to the company.
I admit to being inclined to do so in this case, and that certainly doesn’t mean they won’t have a contaminated sample tomorrow!
Product quality and safety assurance is the primary remit of an FDA inspector. As a part of the Public Health Service which has been in existence since 1798, I think we can agree that assuring the quality of production placed into interstate commerce which is impactful to public health, particularly consumables, is something that has had precedent since the Nation's earliest times.
As a fellow New Englander you'll likely recall significant contamination problems which engulfed places like Copley Pharmaceuticals, Canton, MA (metered dose inhalers bacterial contamination) ~1998, Genzyme, Arlington, MA (contaminated biologics) ~2009, Lonza Biologics (sterile fill and finish microbial contamination) ~ 2011 and New England Compounding Pharmacy, Framingham, MA (64 patients killed, >800 sickened) ~2014.
My consulting firm does regulatory compliance assessments for pharmaceutical, biologics, device, food/nutraceutical and cosmetic manufacturers world-wide. We prepare clients for FDA inspections and often accompany clients during FDA inspections. We remediate the findings of FDA inspections.
Sometimes (rarely) FDA will get something wrong in an inspection. Example: Chinese manufacturers of heparin made for Baxter Healthcare (2009) took FDA to the wrong plants for inspection and FDA missed what were the offending plants. Heparin imported from offending plants was contaminated and killed 150 in the US and injured 350. Fraud investigations against ensued against the manufacturers. Offending exporters were subsequently banned. Significant fines assessed.
FDA takes product contamination and product adulteration seriously. It is why the US has the purest best manufactured drug supply in the world, and avoids contamination events impactful to the public in most cases.
Continued regulation in this space is not something that the public will welcome nor is it something Trump wishes to curtail. I think he wants to lower the hurdles for new drug approvals and do so more in line with meaningful risk based approval processes to streamline things (I was once a Review Chemist who served at FDA and was responsible for review and approval of manufacturing submissions for drug products.)
I understand, I have a degree in Chemistry and work in a highly regulated environment, so I understand these things.
Don’t get me wrong-I am not one of those people who wish to banish all things government-I understand there is a role.
I simply feel that there is over-regulation in many areas, of which the FDA is one of them.
But I also feel that tort reform is a key as well.
As a PhD medical microbiologist I agree that “I would personally speculate that it is just as possible that the incompetent FDA contaminated their own samples.” especially if there is a little grifting or just plain swindling on the line going on.
The FDA as a whole and each division and each person must have a thorough and competent examination. I just wonder how old their procedures are, etc., and if their “scientists” are not going to yearly or q 2-3 year qualification updates. The result is they either get fired or get them. Microbiology and all its variants aren’t static and must not be.
How can cheese be “bacteria free”? Bacteria is part of the process in most cases.
I hear what you are saying, but I also know that having all the requirements for qualification, being qualified, having valid and reliable processes and procedures, and actually following those procedures are all chains of a link, and rendering any single link invalid can invalidate the entire process!
This I all know from personal experience.
Sigh. I am sure there are many parts of the FDA in which all of these factors are spot on and I unfairly maligned some. Or they may all be good and conscientious workers, but their processes or systems have holes. I have just developed a knee jerk reaction, and take the side of a company or person over a big bureaucratic federal agency. It’s a weakness, I know.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.