Thursday, May 31, 2007

USDA Policy

Just when I think I've heard it all, this administration manages to surprise me again.

So says Hilzoy of Obsidian Wings. UPDATE: Hilzoy has issued a retraction. Would that all bloggers, including myself, could respond to criticism as gracefully as this.


What about?

This story:
The Bush administration said Tuesday it will fight to keep meatpackers from testing all their animals for mad cow disease.

The Agriculture Department tests fewer than 1 percent of slaughtered cows for the disease, which can be fatal to humans who eat tainted beef. A beef producer in the western state of Kansas, Creekstone Farms Premium Beef, wants to test all of its cows.

Larger meat companies feared that move because, if Creekstone should test its meat and advertised it as safe, they might have to perform the expensive tests on their larger herds as well.

The Agriculture Department regulates the test and argued that widespread testing could lead to a false positive that would harm the meat industry.

A federal judge ruled in March that such tests must be allowed. U.S. District Judge James Robertson noted that Creekstone sought to use the same test the government relies on and said the government didn't have the authority to restrict it. - A federal judge ruled in March that such tests must be allowed. The ruling was scheduled to take effect June 1, but the Agriculture Department said Tuesday it would appeal, effectively delaying the testing until the court challenge has played out.
Hilzoy goes on to say:
I fail to see what the government is doing in this case to start with.Rick Perlstein (note: Perlstein uses 'E. coli conservative' to refer to conservatives whose commitment to small government extends to things like food safety):
"First, observe the contempt for liberty. When E. coli conservatives say self-regulation is preferable to government, they're even lying about that. Second, observe the contempt for small business. When a small company want to - voluntarily! - hold its product to a higher standard, the government blocks it, in part because bigger companies have to be protected from the competition, in part because a theoretical threat to the bottom line (false positives) trumps protection against a deadly disease."
As I said above, I can see a theoretical case against widespread testing for some things, if they're rare enough and the costs of missing cases of those things are low. But the way to do that, I would have thought, is not for the government to ban testing; it's for firms to get together and adopt some sort of common policy. It is not the government's job to protect companies' profits, especially not by preventing them from testing for a fatal, incurable neurodegenerative disease.
A few points:

1. The reason the government is "in the case to start with" is that Creekstone Farms filed a lawsuit against the Department of Agriculture.

2. The bolded text above is false, at least as concerning the lawsuit, and shows the danger of trusting anything that a journalist says about a legal proceeding. (I've discussed this before).

In the lawsuit, the government did not make an argument about "false positives." To the contrary, the government's brief in support of a motion for summary judgment (as well as its other briefs) argued that BSE tests would provide a overwhelming number of false negatives. Here's a long quote from that brief:
As discussed previously, the vast majority of cattle that are processed into beef in the United States are less than 24 months old. See Ferguson Decl. ¶ 5. However, the average incubation period for the BSE disease is five years, meaning that on average it takes five years from the date a cow is infected with BSE for the cow to show any outward clinical signs of the disease, such as abnormal posture, inability to walk, or other impaired coordination. See id.

Given that the earliest point at which current BSE testing methods can detect a positive case of BSE is only two to three months before a cow would demonstrate clinical signs of the disease, see id. ¶ 10; Rippke Decl. ¶ 9, testing all young normal-looking cattle for slaughter, as proposed by plaintiff, is not practical and offers no animal health or food safety value because testing a young infected animal with the current methodology would likely produce false negative results, Ferguson Decl. ¶ 10.23. Accordingly, when used to diagnose the presence of BSE in all cattle for slaughter, as proposed by plaintiff, BSE test kits are worthless and subject to regulation under [Virus-Serum-Toxin Act].
The false negative argument was also made in a 2005 rule from the USDA, which found universal testing to lack any scientific justification:
We understand the interest expressed by some commenters in testing certain cattle for slaughter. However, no live animal tests exist for BSE and the currently available postmortem tests, although useful for disease surveillance (i.e., in determining the rate of disease in the cattle population), are not appropriate as food safety indicators.

We know that the earliest point at which current testing methods can detect a positive case of BSE is 2 to 3 months before the animal begins to demonstrate clinical signs. We also know that the incubation period for this disease–the time between initial infection and the manifestation of clinical signs–is generally very long, on the average of about 5 years. Accordingly, we know there is a long period during which, using the current methodology, testing an infected animal that has not demonstrated clinical signs of the disease would, incorrectly, produce negative results.

* * *

Testing of individual animals, especially if it is performed on clinically normal animals at slaughter, is not in itself an effective risk mitigation measure for protecting public health. The purpose of a surveillance program is to gauge the level of BSE prevalence. This can be achieved through targeted sampling, as is being carried out in the United States and Canada.

For these reasons, we do not consider the testing at slaughter of every bovine over 20 months of age, or the testing of every bovine at slaughter, to be scientifically justified or meaningful in the context of either human or animal health. Making this a criterion for minimal-risk regions would not contribute to human or animal health protection beyond the protection achieved by a statistically and epidemiologically valid surveillance plan, coupled with the risk mitigations specified in this rule.
3. Why is the government taking this position? I see no evidence, as of yet, that concern for "protect[ing] companies' profits" has anything to do with this. Instead, this seems to be a perfectly normal case of the liberal regulatory state protecting its turf.

To briefly summarize the USDA's argument:

A. The Virus-Serum-Toxin Act provides, in relevant part, that no one can sell "any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals."

B. The Act also allows the USDA to issue rules and regulations to enforce this prohibition.

C. According to the USDA's official interpretation in 9 C.F.R. 101.2, an "analogous product" includes substances that "act through the stimulation, supplementation, enhancement, or modulation of the immune system or immune response; or . . . through the detection or measurement of antigens, antibodies, nucleic acids, or immunity." That includes the BSE test, among many other things.

D. Under that same regulation, diagnostic tests are part of "treatment."

E. Under official USDA policy, "the sale of BSE test kits is restricted to laboratories approved by State and Federal animal health officials for use in APHIS’s program of BSE surveillance." This is why Creekstone had to ask permission from the USDA to buy BSE test kits in the first place.

F. But because so many false negatives would result from testing young animals, using tests in that way would be "worthless" under the statute.

Of course, I have no idea whether the BSE test is useful and when, but if the USDA is right that the test is completely worthless when performed on live young cattle, then its overall argument doesn't strike me as crazy or ideological. Indeed, the Virus-Serum-Toxin Act -- a piece of progressive legislation passed in 1913 -- requires the USDA to prevent such "worthless" products from being sold. Again, it's just the liberal regulatory state in action.

By the way, the federal district judge granted summary judgment to Creekstone because, while he agreed with just about all the steps in the USDA's argument, he thought it contradictory in one respect:
It is unnecessary to reach the question of whether BSE test kits are “worthless,” because their use may not be regulated under the VSTA unless they are both “intended for use in the treatment of animals” and “worthless.” The government may indeed be right that the tests are “ineffective, misleading, and essentially worthless . . . when used, as proposed by plaintiff, to diagnose the disease in all slaughter-aged normal-looking cattle.” Def.’s Mem. at 42. But. . . let it be noted that the government cannot have it both ways: the test kits cannot be both “used for treatment” and “worthless.”
P.S. The USDA's rule linked above, was upheld by the Ninth Circuit, in an opinion written by Clinton-appointed judge Wallace Tashima, and joined by Clinton appointee Richard Paez:
Finally, the district court held that it was arbitrary and capricious for the agency not to require all Canadian cattle to be screened for BSE, because the screening test could identify some animals with BSE that would not otherwise be identified. R-CALF I, 359 F. Supp. 2d at 1069. The Final Rule, however, contains a lengthy comment in which USDA responded to requests for testing of Canadian cattle. Final Rule, 70 Fed. Reg. at 475-76. USDA explained that, because testing can only detect the disease two to three months before a cow starts demonstrating clinical signs of the disease, a cow may be infected and thus produce a false negative on a test. Id. Because of the long incubation period of BSE, and the relatively short window in which non-targeted testing is effective, the USDA did not consider testing to be a “food safety” measure. Id. Rather, testing was best used to determine if BSE exists in a country and to determine its prevalence — goals that can both be achieved by targeted testing of animals with clinical signs of BSE. Id.

Over the past few years, USDA’s policies regarding BSE testing have been subject to a high degree of criticism. See, e.g., Mad Beef Policy, Los Angeles Times, Jul. 1, 2005; McGarity, supra, at 337-40. These criticisms have generally focused on USDA’s refusal to allow voluntary testing of cattle, rather than its refusal to require mandatory testing of Canadian cattle. Although these criticisms are not without their valid points, we do not believe that they are so powerful as to render USDA’s testing policy invalid. USDA’s approach to BSE testing — that, until better tests are developed, prophylactic measures such as the feed ban and SRM removal are the best methods of protecting human and animal health — is defensible. While its wisdom may be subject to debate on the merits, its choices are not so lacking support in the administrative record as to be “arbitrary and capricious.”
P.P.S. Hilzoy began the post, "Just when I think I've heard it all, this administration manages to surprise me again." Even if it were true that the USDA was just trying to protect large beef producers, this wouldn't really be that surprising. See George Stigler's "Theory of Economic Regulation" article.

P.P.P.S. Could the USDA have been worried about market protection despite the fact that its briefs never mentioned such a theory? Possibly, but again, if the USDA is right about the efficacy of the test, then this concern would have been rational. If a company uses a "worthless" test that will produce only "false negatives" (given the long latency period of the disease and the age at which cattle are slaughtered), then it would be false advertising for a company to claim that this worthless test made its beef any safer. Of course, that may be why the district judge said that this whole case may be more a matter for the FTC.

P.P.P.P.S. Why are false negatives so different from false positives here? If testing tended to over-diagnose mad cow disease, yes, there would be false alarms, but that would be from erring on the side of safety. But if widespread testing here would provide false negatives, it would not increase or err on the side of safety. Quite the contrary: Testing would provide a false sense of security, because it would overlook cows that might actually have the disease.

P.P.P.P.P.S.: Maybe the AP wasn't totally crazy here. I just noticed a footnote in the district court's order that says this: "Of greater concern is the possibility that private testing could produce a false positive result, which might trigger
unnecessary public alarm. USDA has asserted this possibility as a reason to avoid private testing." Here's the thing, though: The court doesn't cite any filing or rule in which USDA made this argument, and I could find no references at all to "false positive" in any of the government's briefs. Maybe a USDA lawyer mentioned this offhand at oral argument. In any event, the "false negative" point was definitely the USDA's main argument.


Blogger anomdebus said...

A question is what the relative risk of infection from these relatively young infected cows? If a test can't detect it, perhaps the incidence in the flesh is also likewise diminished.
Another question would be why rely on tests that are probably going to return a negative even if the individual is infected? In the end, isn't this just like advertising that lard has zero sugar and granulated sugar has no fat?
If the FDA wants to regulate this industry, it could just as well mandate a disclaimer on the advertisement stating the uncertainty of the result.

5:07 PM  
Blogger Unknown said...

The cause of mad cow in the US is known, but is politically incorrect. It is illegal to use the byproducts from cattle to make cattle feed. However, the byproducts of hunter's deer or elk butchered in some small meat packing plants gets used to make wild animal feed. In turn game farms give this feed to deer and elk to complete the cycle of infection. In 2001 CBS reported the extent of infected animals, but claimed ignorance on the cause:

On occasion some hunter who also raises cattle tosses in a bag of wild game feed along with his cattle feed and bingo, you get a mad cow. Fortunately for the industry this is rare, but unfortunately deer and elk hunters suffer the consequences of greed and corruption. The meat packing industry wants deer and elk infected to drive people to the grocer instead of harvesting deer and elk for meat.

12:32 AM  

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