This really makes me crazy. I've already ranted about it at least twice (here and here), going back to January 2005. I thought this one was settled in the only way commonsense would allow. But commonsense isn't very common with some judges.
Here's the gist. Back in 2004 a small meatpacker, Creekstone Farms, wanted to test its cattle for mad cow disease (BSE or bovine spongiform encephalopathy). There is no cure for BSE. In fact there isn't even a treatment for it. It's fatal 100% of the time. The best you can do is prevent it. You do this by not allowing cattle that harbor the agent, an infectious prion, into the food supply. But to test for BSE in the US you need government permission first. Yes, that's right. Permission to test to see if their product is safe. No problem, you think? Except that the US Department of Agriculture (USDA) refused to give permission to Creekstone Farms to test 100% of its cattle (instead of 1%) on the grounds it would give them an unfair advantage over competitors who weren't testing. I'm not kidding. I wish I were.
Creekstone wanted to test because they were at a competitive disadvantage. Japan had placed a ban on US imports when some cattle with BSE were detected in the US. Japan required 100% testing and because Creekstone wasn't allowed to do this they lost their export business and wound up laying off 150 workers and reducing the remaining 650 workers to a 32-hour workweek, all this in a town of only 12,000. So they went to court and a Federal judge ruled against the Bush administration, saying that the USDA exceeded its authority under the 1913 Virus-Serum-Toxin Act which allows the agency to regulate products intended for the treatment of domestic animals. Since these are diagnostic kits for an untreatable disease you would think that would settle the issue. But the Bush administration appealed it to the government friendly DC Circuit Court of Appeals who, in a 2 to 1 split decision, ruled that the law seems to include diagnosis as part of the treatment of animals. I guess that means you can't diagnose untreatable diseases according to the law. Or something.
The Blog of Legal Times notes things aren't quite over. The Appeals Court remanded the case back to the District Court to rule on whether the USDA acted arbitrarily and capriciously in refusing to let Creekstone test its cattle.
USDA arbitrary and capricious? Ya think?
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There used to be a preliminary test with a relatively high false positive rate and a follow-up test with a lower false positive rate. Is that still the case, and what are the false positive rates of the two tests?
It is usually considered a bad thing if the incidence of false positives is greater than the incidence of true positives found by the test. With millions of cattle and so far only three or four true positives, that might be a problem. Do any countries cut off trade as a result of a positive on the first test?
I agree with john that interpretation of the test results may not be as straightforward as a lay person might think.
But I can't see how that justifies telling anyone they're not allowed to perform the test at all. (I assume we're talking about a test that meets applicable regulations here, not something unproven that the company came up with.)
It may well be appropriate for USDA to regulate how Creekstone uses the results of those tests. For instance, there may be good imagine arguments that Creekstone shouldn't be allowed to promote their meat as "BSE-free" based on such testing.
But saying they can't even perform the test? Sounds like USDA is protecting someone's interest here, and I don't think it's the public's (or Creekstone's).
I'm going to play devil's advocate here and propose the following: I propose that we envision and design an agency that looks after the safety of all the food in the country, the effectiveness of all the drugs in the country, and the oversight of the systems that are involved in delivering said food and drugs to the consumer. Then I propose that we do this on the cheap.
We would be hard-pressed to come up with an agency unlike the FDA. It is an agency with bureaucrats at the top whose job it is to answer to pressures from Congress and the President (who are, in turn, influenced by their benefactors). Epidemiologists, food scientists, and technical staff have no say, really, in the regulations that FDA puts forth. Sadly, the same is true of CDC.
Perhaps if a panel of ordinary citizens, all making less than $50 grand per year who have the common sense to make do with what is available, were given the authority to oversee FDA, to hire and fire as they saw fit, maybe then things would change... And they would probably change for the better.
Ren: I'm not sure it is a Devil's Advocate position, since many public health people are deeply dissatisfied with FDA, USDA, CDC, etc. But if you permit me, having been in medicine and public health for 40 years, the agencies you see today have not always been that way. Even under Republicans in the past we have never seen anything as broken as the Bush administration agencies. The level of incompetence and corruption surpasses any historical precedent. So before we try to cure a disease with powerful meds, we should see if more feasible therapy will bring these public safety agencies back to life. I'm not sure if it is possible but the last 8 years have been anomalous in many ways (although not in all).
There seems to be a view common in your Republican party - and to a lesser extent to both Labour and the Conservatives in the UK - that if it's a government agency it must be a bad thing, so it doesn't matter if you make it even worse by underfunding and political interference.
BSE was obviously a big problem here in the UK a few years back. British beef exports were hit very badly, even after the initial quarantine was lifted. The opinion here was that many countries were using the disease as an excuse to support their home producers, when their own raes of infection were no better.
In this particular case, I could believe that the FDA bureaucrats are afraid to let thorough testing take place in case they learn something inconvenient. Although that would depend on the test being effective: if it doesn't give reliable results - particularly a lot of false positives - I could well understand why they wouldn't be keen to see a lot of testing.
The cost of false positives is borne by the meatpacker. Depending upon the rate it can be costly to do the required confirmatory follow-up with more specific tests but in this case it is the meatpacker that wants to do it. I don't see an excuse for this. The USDA can always prevent them from advertising there meat is safe if they wish. These guys want to meet import requirements overseas.
No. Unfortunately, the USDA is not arbitrary and capricious in this instance. That would at least be understandable or at attributable to incompetence. The current situation indicates that the USDA is very effectively carrying out its perceived mandate to protect the producers from the consumers. For those of us who perceive their mission to protect the consumers from producers who play fast ansd loose with food safety issues, well that is just too bad.
Well here is my read on it. Dont sue them, let them sue you. Test 100% and to hell with the FDA. Its a cow, not a human. If there is any politics in it you would use the reverse brain process here. Let them sue you and then the wheels would jug around and someone in Congress would act.
After you posted on this Revere, I looked at the regulations and a bovine operation can test for anything that they want. The only problem? They cant advertise it and thats where this true rub comes in. The unfair advantage runs to about 1/2 dozen laws in Commerce and Trade, USDA, Truth in Advertising...etc.
USDA isnt acting capriciously. They said fine, test but you have to use it internally not externally. Just a little clarification here. Fucked up? Revere its the government... could we expect anything different?
Not if it were the military, anyway.
Why are you so surprised that owners can't test their own cows for BSE?
As the (presumed) owner of my own body, I can't obtain routine lab tests on myself (CBC, glucose, chem panel), and since the new medical paradigm deems these tests unnecessary without a show of symptoms, there's no way for me to obtain that (useful!) information.
Why should a cow's owner have more rights in that regard than I do?
What I don't get is that there's no law that mandates testing of every single slaughtered cow. Japan is not the exception, the USA is! I don't understand why there hasn't been a metaphorical (or real) bloodbath among US politicians when they didn't introduce such law the day when the first case of BSE was confirmed in the USA. Over here, there would have been.
Something is rotten in the States of America.
See, BSE is different.
OK, David, I know BSE is different, and I also think farmers should have the right to test for whatever they want.
My point was: So should I! Why should I not be able to diagnose a subclinical case of liver failure or diabetes or whatever in myself before the damage is done? To limit this to BSE and cows is to miss the point. And that point is? Stop making regulations that limit my access to information, about my food, my body, whatever.
MRK et all. The point is that beef exporters are banned from testing their cattle for mad cow disease without approval from the government, since they have exclusive control over the test kits. They can not buy the kits to do the testing.
The law gives USDA the authority to control test equipment used in the treatment of illnesses in animals like cattle(1913 was a very bad year, this law, the fed, Income tax, etc). However, the test kits are required to DIAGNOSE if they are ill, there is NO treatment, other than witholding the meat from the market and prevent it from being consumed by humans. As indicated here, the courts are ruling DIAGNOSIS is simply one element of treatment. If you don't test for it, it does not exist, except perhaps in computer models which can prove cows can fly given enough free parameters.
Pft-Now I have seen cows fly before, just not very well.
I am interested. Does the EU test all of their cows for BSE or just G.Britain? I emphasize the all. Anyone know?
Kathleen --
You make a good point, but it sounds like there's a crucial difference between the tests you'd order for yourself and the tests Creekstone Farms wants to run on its cattle: namely, Creekstone itself could run the tests.
I don't think the tests you mention are ones for which home kits have been designed, meaning you'd have to draw blood, package it, and ship it securely to a lab. You yourself might be capable of doing that, but there are legitimate reasons for the system not to place those responsibilities in the hands of non-professionals.
Furthermore, if anyone (who could pay for it) could send blood to a lab without any sort of gatekeeper, the labs we have would be overwhelmed. In time capacity might catch up to demand. But in the meantime, I wouldn't want me, or a family member, or you for that matter, if we happened to be showing clinical symptoms, to have our lab results delayed or worse because a thousand people who weren't sick decided to get a CBC, or a chem panel on their teenage kid.
As I mentioned, there are kits for some things -- home HIV tests, for example, or (sketchy) DNA screening, which you send off. Those kits exist because there was a market that manufacturers have perceived, and that they can design effective kits for. Maybe if they saw a demand for home CBC or diabetes testing or whatnot, they'd design those too.
I think the sticking point there is that a) unlike HIV, these are tests people aren't that concerned about confidentiality, and b) unlike DNA testing, these are tests which most doctors will order if they see cause/are prodded. So the market may not really be there. (Such kits might be very useful for people who have a hard time seeing a doctor due to lack of insurance, but the labs could run them hundreds of dollars, so most still might not be able to afford them.)
I don't think people being able to purchase their own routine lab tests would overwhelm the labs, since this is already an accepted practice in some places. In Arizona, for example, there are health fairs that perform these services for people (for cheap!), and in California there are other tests that people can self-order (bone density, various ultrasounds, cholesterol testing). True, these are not tests that are done with home kits, but I don't think that's a significant distinction.
Creekstone should be able to run the BSE tests, whether in a lab or with a kit--it doesn't really matter HOW it's done (as long as it's reasonably accurate), and as a consumer, I should be able to CHOOSE only BSE-checked beef (assuming I wanted to buy or consume beef, which I do not). I should be able to choose food free of nano-crap too, and free of bpa, etc., and Japan should be free to purchase only BSE-tested beef--it's their money and it's their choice! Basically, it's all information, and as an adult, I should be able to access that information.
Truth be told, the USDA has just one reason for disallowing BSE testing, and that is their connection to corporate farming. Corporate farming has made it clear that they do not want the expense of testing (and probably couldn't care less if a small percentage of beef-consumers end up killed by BSE--just a cost of doing business, like the Pinto gas tanks and those subsequent lawsuits). What corporate farming wants, corporate farming gets, and if that means some of us and some smaller farms don't get what we want, well so what?
As long as American consumers choose to eat burgers "manufactured" by modern beef machines wading in excrement, corporate farming will continue to exist to satisfy that desire, and if things like BSE-testing get in the way of feedlot "efficiency," they will be eliminated. It was never about the consumer.
USDA actions about the BSE testing are correct. WHY?According to my opinion mad cow disease (BSE) is not an infectious disease. See my recent presentation at 29th World Veterinary Congress in Vancouver (http://www.meet-ics.com/wvac2008/pdf/PS1-3June2008_003.pdf) ; Neurodegenerative Diseases and Schizophrenia as a Hyper or Hypofunction of the NMDA Receptors. There is the abstract about this article;
Neurodegenerative diseases, including BSE, Alzheimers disease etc. are caused by different mechanisms but may share a final common pathway to neuronal injury due to the overstimulation of glutamate receptors, especially of the N-methyl-D -aspartate (NMDA) receptor subtype. It is generally accepted that the influx of Ca2+ as a result of excessive activation of the NMDA receptor underlies the toxic actions of glutamate in many systems. Also, ammonia intoxication leads to excessive activation of NMDA receptors in brain. On the other hand, Mg2+ competes with Ca2+ at voltage- gated calcium channels both intracellularly and on the cell surface membrane. So, Mg2+ can protect against NMDA- induced neurodegeneration and Ca2+ deficiency can be important about "NMDA hypofunction" in schizophrenia. In addition there can be another example about hypoglutamatergic condition; cannabinoids are known to inhibit Ca2+ channels- glutamate release in schizophrenia, and to inhibit progression of certain neurodegenerative diseases.
There are no scientific references to date in which high intake of crude protein (and potassium) high enough to lead to a state of hyperammonemia (and hypomagnesemia) during the incubation period of the BSE. Therefore there is the first idea of this review; to show the hyperammonemia plus hypomagnesemia"simultaneous" action on the ruminant tissues. So the various clinical symptoms can be observed because the nervous system controlling both voluntary and unvoluntary muscles is affected (Mg and Ca disturbances). If the BSE is involved; a longer- chronic action of corresponding biochemical changes in the blood (CSF) is necessary, to rise irreversible neurodegenerative changes.
Recently was found that elevated manganese in blood was associated with "prion infection" in ruminants. These findings about "manganese theory" act in concert with this "BSE ammonia- magnesium theory". So I will perform some interpretations about this connection and some details will be presented to the Congress, and also second idea of this review; to show that cannabis use can be a proof about the link between the NMDA receptor hyperfunction (neurodegeneration) and hypofunction (schizophrenia).
Comments about this abstract; as a proof concerning Mg-deficiency (and hepatopathy; see www.bse-expert.cz) , according to the alternative BSE ammonia- magnesium theory;
1. In biological systems, only Mn2+ is readily capable of replacing Mg2+, and only in a limited set of circumstances. The body can replace Mn with Mg with similar efficiency in Mn-activated proteins (1990). Similarly, Mn can occupy Mg allosteric sites in Mg-activated proteins, such as the sarcoplasmic reticulum Ca- ATPase (1981). It was found (1999) that feeding rats a diet deficient in Mg; decreased urinary - fecal Mn excretion and greater Mn retention in skeletal muscle, heart and kidney (except the liver and trabecular bone) in Mg-deficient rats was observed.
2. Other cause about Mn deposits in tissues is liver disease. People with chronic liver disease have neurological pathology and behavioral signs of Mn neurotoxicity, probably because elimination of Mn in bile is impaired (1994- 1996). This impairment results in higher circulating concentrations of Mn, which then has access to the brain via transferrin. It was reported that whole blood Mn concentrations significantly increased in patients with chronic liver disease.
Josef: Whether you are correct or not (and you will have to admit you are out of the consensus on this), you reasoning is not behind the USDA decision. USDA does not believe, as you do, that the mainstream scientific consensus is wrong. They believe in protecting the big producers.