Screen shot 2010-10-28 at 4.17.52 PM.pngBoy, have I heard it from the raw milik, locavore, anti-government folks over the last few days.  I now agree with them.  Big agribusiness and small local farmers should be treated the same.  Any company with several months of Listeria problems and an inspection report like this, should be shut down.

Observation 1. Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

Observation 2. Failure to take necessary precautions to protect against contamination of food and food contact surfaces with microorganisms and foreign substances.

Observation 3. Employees did not wash hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.

Observation 4. Suitable outer garments are not worn that protect against contamination of food and food packaging material.

Observation 5. Failure to take effective measures to protect against the inclusion of metal and extraneous material in food.

Observation 6. The materials and workmanship of equipment does not allow proper cleaning.

Observation 7. Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.

Observation 8. Failure to store cleaned and sanitized portable equipment in a manner which protects food-contact surfaces from contamination.

Observation 9. Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.

Observation 10. Failure to wear hair restraints where appropriate.

Thanks to efoodalert for the FDA inspection report.

  • Greg

    Is this producer small enough to be exempted under the small business exemption amendment attached to S510? That would be very bad.

  • No doubt. I am sure that they make less than $500k and sell within 400 miles to individuals, restaurants, grocery stores or farmer markers.

  • If you were in touch with the raw milk producers, I’m sure you got an earful. I did.
    I blog various topics that I see in international news – a bit of a self-education hobby using the biggest library ever. Being lazy, I figure often people have said what needs to be said better than I would – and have the bonus of finding things out during exploration.
    So it was that I found a chap at Care2 – he’s no longer an active member – with the darndest talent for insider information on dairy matters. Having a Dairy Plant Worker’s Certificate myself – the first year it was issued- I found his perspective interesting. I worked in small cheese plants using what were even then antiquated methods and was able to note changes from ‘modernization.’ “Ahem”
    To make a long story short – he and a retired Ohio farmer are inveterate bloggers. Since I follow blogs…voila. A post. Two in this case by the time I threw in related materials.
    The reason I think you might find these interesting is simple. I expect, given what I have read, a reasonable prognosis to be ever worsening and even calamitous failures. These will be from compromised immune systems, unsanitary crop raising techniques, routine use of antibiotics in raising livestock resulting in proliferation of resistant organisms……really a case where the industry could not be more aimed at a collision course with failure than if it were designed to proliferate disease.
    That could be the case…but that’s a far wilder matter yet.
    August 13 2009 relate their representations and blogs on two obvious posts. A post on Current TV’s Water news group ( Aug 15th? ) actually refers to people who do ag news as well. And Corporate Farming in the Topical Index ( sidebar ) should more than put the cap on what any sane person would want to know.
    The ‘Home’ link is an Infomercial hosted on its own channel on YouTube. At the time of its release it was hosted by at least 3 facilities to get it going. Highly recommended – educational and entertaining 1 hr 37 min

  • L.E. Peterson

    In FSIS, noncompliance reports like this that accumulate over time generally trigger a Food Safety Assessment at best, and a Notice of Intent to Enforce and possible plant closure if the plant doesn’t comply within 72 hours. If FDA had the resources to inspect more plants, more often, I doubt Estrella would have reached this level of problems. I’ve had the opportunity to tour a number of commercial dairies and I’m also the daughter/granddaughter of former dairy farmers. Those operations were spotless compared to this one.

    Unfinished Wood shelves? Really? In this day and age when stainless steel and other easily cleaned and sanitized materials are available? I’m appalled. I have a set of NSF-food service approved shelves in my kitchen that I bought at Lowe’s for a fairly reasonable price years ago.

    FSIS barely tolerates wood pallets in the meat processing facilities because they are impossible to keep clean and if the plants don’t pay attention, they sometimes come in with pesticide residues from fumigation at the ports of entry. If the plants keep them replaced on a fairly regular basis, its the best we can hope for as inspectors. I’d personally love to see plastic pallets in the plants but they are allegedly “cost prohibitive”. It’s going to be up to the customers to tell their suppliers to get rid of the wood pallets. *sigh*

  • Cheese has been aged on wood shelving for centuries. These days, wood shelving is actually fairly common in the cheese industry. Some jurisdictions allow it and some don’t; some require mats on top of the wood shelving. There are a number of cheesemakers in the Pacific Northwest that use wood shelving with their inspector’s approval…this particular accusation may be a case of the state and fed regulators not coordinating their efforts.

  • Eamon

    A lot of stores carried Estrella. I wouldn’t be surprised if their sales are over $500K. The Tester amendment doesn’t fully exempt small producers from regulations, particularly those handling hazardous foods like meats and cheeses. The Tester amendment doesn’t preempt state laws either.

    L.E. Peterson put it best: this situation wouldn’t have gotten to this state if there were more frequent inspections. The FDA needs resources to conduct inspections more often. S.510 is worthless if there is no money to carry it out.

  • Bill Anderson

    It speaks volumes to the bias, misinformation, and inaccuracy of this report that wooden shelves are cited as a problem. It is just like the example of replacing a removed core sample of cheese for grading was cited as a problem, when this is a standard accepted practice amongst professional dairy scientists and cheese graders.
    Curing cheese on “undressed lumber shelving” is a very common practice. In fact, two of the top three cheeses made in America this year, as determined by the prestigious American Cheese Society, are cured on such “undressed lumber shelving.” I was in one of those creameries earlier this year in Vermont, and can send you my photos of their “undressed lumber shelving and support structures” which cures one of the top cheeses in America.
    Bill Marler, you make me abolustely sick. Literally. Your continued war on nutrient dense traditional food is killing hundreds thousands of people every year because of chronic lifestyle diseasess. Maybe you can stop a few accute E. Coli and Salmonella outbreaks with your campaign for sterile food, but the body count from all who die because of this ongoing corporatization and dumbing down of our food supply combined with dependence on pharmacuticals speaks another story.
    Can you even acknowledge the possibility that the FDA is misrepresenting the facts because of a political agenda? Can you even acknowledge that you have no first hand knowledge of this cheese making facility, and that you are trusting an agency with an unabashed political agenda against raw milk to inform you?
    Or are you going to continue parroting FDA propoganda? Are you going to continue putting all your faith in the government to tell you what foods are safe to eat?
    Curious minds want to know, Bill Marler.

  • Bill, both Wright County Egg and Hillandale are back in business. Wright County can sell only to “breakers” who pasteurize the eggs. Hillandale can sell eggs. Both agreed to recall 550,000,000 eggs and were shut down until FDA determined they could reopen. Both companies have lost market as many retailers refuse to buy the product. Both are facing both criminal and civil investigations.
    Other than you personal attacks, I appreciate your comments generally. I do think that raw milk and raw cheeses are under far greater pressure than other manufacturers. I do think that it is unfair. I think all manufacturers should be under similar scrutiny.

  • Bill Anderson

    Under far greater pressure yes, and with far fewer resouces, I might add. Dairy is the most corrupt sector in agriculture, after all. When “Milk is Milk” (all milk is the same) is the official USDA dairy policy, you know we’ve got serious problem.
    Let me tell you… not all milk is the same. Morning milk and evening milk are different. Milk from different breeds, at different stages of lactation, at different times of the year, grazing in different regions are all vastly different.
    I have witnessed firsthand how inspectors have great judgement… that is to say, if they want to find problems they can find them. It has nothing to do with food safety. It has everything to do with political and/or personal agendas.
    The starting point of true food safety begins with respect for tradition and for the most natural ways of doing things. When you are a germophobe and fanatical sanitarium, there can be no respect for tradition or nature, and thus no food safety.
    The French make a point of protecting their local regional traditions in raw milk cheese, using legislation known as AOC (Appelation of Origin Control). Americans are making a point of allowing no traditions to be established at all, using legislation known as SB510.
    I attack you, Bill, because you blindly parrot FDA, and agency which is notorious for its bias and war against the natural way. You are only making our food supply less safe by shilling for FDA.

  • L.E. Peterson

    Traditional practices such as wood shelving do not mean the wood is sanitary. The establishment has to take measures to keep those shelves clean. The inspection report clearly indicates that the shelves were not being kept in a sanitary manner. Unfinished wood is extremely hard to sanitize because wood is a porous material. Listeria is notorious for developing biofilms that are even difficult to remove from stainless steel.

    In all likelihood, FDA inspectors may not be familiar with a lot of cheese industry practices–they are expected to review all types of food plants and they don’t spend much time in any of them. My understanding is that most of their inspections involve looking at paperwork but I can’t say that for certain–just something I’ve heard through the grapevine. Most FSIS inspectors have worked in the meat plants before entering the inspection force so they know the processes. I’m a farm kid so I’ve spent my whole life dealing with the meat industry starting at the farm all the way to making pork eggrolls. I know the whole process of turning a steer into a steak so to speak. If you took me out of the meat plants and threw me into a cheese plant, I’d probably have no clue what to do but I’d make a point of learning the process. You can’t regulate something you don’t know about.

    I can tell you that the FDA’s problem with the tasting procedure was the fact that the taster was only wiping the trier with a rag instead and sanitizing it every time. She also failed to wash her hands between handling the different cheeses she was tasting. She could have been easily transferring the Listeria from contaminated product to non-contaminated product because of this. They probably wouldn’t have even mentioned the tasting procedure if she had taken the cheese to a clean inspection area, sliced a piece of cheese off the plug to taste before replacing it, cleaned/sanitized the trier and washed her hands. It’s the little things that will burn you in an assesment like this.

    GMP’s are required by FDA regulation (check out the 21 CFR) and from this inspection report there were several instances listed of the failure to follow basic good manufacturing practices such as hair nets, protective smocks/aprons, handwashing etc. These things may not sound like a big deal at first but when they are not used, they contribute to spreading pathogens around the plant. Workers have to get into the habit of doing these things and it’s up to management to set the example. In Estrella’s case, the owner wasn’t even following proper GMP regs.

    If FDA does things like USDA (and for the most part they don’t), the listeria positives triggered an automatic Food Safety Assessment and the inspection report reflected conditions that contributed to the Listeria problem. In FDA’s case, apparently one report to support insanitary conditions is all they need if there is a history of positive test results. Ideally, there should be multiple sanitation noncompliance reports to establish a trend of insanitary conditions. It bothers me that FDA is only presenting one report.

  • Doc Mudd

    “The starting point of true food safety begins with respect for tradition and for the most natural ways of doing things.”
    Hmmm. Yeah, whatever. Like food pathogens are somehow not part of nature, part of the evolutionary “tradition” of human existence.
    Tin foil hats flaunted as a fashion statement. Accessorized with lucky rabbit’s feet, no doubt. Yeah, that should work out OK. No worries, then.

  • Jess C. Rajan, Ph.D.

    The following general observations are from a regulatory quality assurance (QA) perspective — and not specific to any food products.
    Laboratory testing procedures have inherent uncertainties. Regulatory testing for the potential presence of microbiological contaminants in food products may have additional uncertainties associated with the environmental sampling.
    Environmental (e.g., floors, drains, walls, air-vents, overhead structures) samples are collected from food production facilities (FSIS Directive 10240.5, Rev2) and are handled in the same laboratories where food products are also tested.
    In the regulatory agency’s laboratory, the microbiological test samples go through an initial “enrichment” step — under optimum growing conditions — to increase the number of pathogens that may be present.
    Present environmental sampling and testing procedures seem to be based on certain assumptions — that the regulatory agency laboratory always has clean environments and follows appropriate sample handling and testing procedures.
    From a regulatory QA perspective, the food safety-related test results may need to be reviewed with a complete trace-back of all the procedures/data from the laboratory — including the data and documentation of credible independent monitoring/oversight of the regulatory laboratory’s (floors, drains, walls, air-vents, overhead structures, etc.) environments.