USDA Declaring Six Serotypes of E. coli as Adulterants

The U.S. Department of Agriculture (USDA) today is declaring six other serogroups of Shiga toxin-producing E. coli (STEC) (O26, O45, O103, O111, O121, and O145). The Agency has determined that they, as well as O157:H7, are adulterants of non-intact raw beef products and product components within the meaning of the Federal Meat Inspection Act (FMIA).


Beginning in March 2012, any raw ground beef, its components, and tenderized steaks that test positive for non-O157:H7 Shiga-toxin producing E.coli strains O26, O103, O45, O111, O121 and O145 will be banned from being sold for public consumption.


The Centers for Disease Control and Prevention (CDC) identified these particular serogroups of non-O157:H7 Shiga-toxin producing E.coli, or non-O157 STEC, as those responsible for the greatest numbers of non-O157 STEC illnesses, hospitalizations, and deaths in the United States.

Proposed Foodborne Illness Reduction Act of 2011 (S. 1529)

Senator Gillibrand introduced bill S.1529 in the U.S. Senate yesterday. The bill is titled as the "Foodborne Illness Reduction Act of 2011''.

Courts force U.S. reckoning with dominance of GM crops

Paul Voosen, New York Times (Oct. 8, 2009), writes that 90% of U.S. soy and cotton crops are genetically engineered (GM crops).  In addition, 85% of the corn crop is also genetically engineered, and it is found throughout the food system. 

     “These crops are safe to eat. The science on that is unequivocal, even in Europe, where a moratorium on new GM crops has existed for a decade. And by most accounts, GM crops have been an economic benefit to farmers, simplifying field maintenance and reducing the number of hands needed for weeding.

     “But as these crops have come to dominate the agricultural landscape, farmers who eschew their growing -- for ethical, organic or trade reasons -- have found themselves at a loss, frustrated by regulators and the majority of fellow farmers who have accepted GM crops as the new normal. . . . For the past two decades, the government has argued "essentially that there's no difference between a GM crop and its nonmodified sibling," said Alison Peck, a law professor at West Virginia University.

     "’Their arguments all sort of flowed from this presumption -- that these two kinds of crops are fungible,’ Peck said.

     “Two recent decisions out of the Northern District of California are the first-time acknowledgement by any federal entity of a difference between GM and non-GM crops, Peck said. The latest ruling, on the GM sugar beets of Willamette Valley, came down late last month and will move into the remedy phase at the end of this month. Both rulings -- the first, upheld several times on appeal, came down in 2007 -- found the regulatory apparatus used by the Department of Agriculture severely lacking. USDA, along with the Food and Drug Administration and U.S. EPA, oversees GM crops, using jury-rigged laws written well before the invention of biotechnology. Unlike Japan, Europe or even Russia, the United States has never passed legislation on GM crops.”

     USDA came to view GE and non-GE crops as identical, fungible. If the farmer wanted to keep GE-genes out of their field, it was that farmer’s burden to provide for buffer zones and other measures to keep out pollen drift. This could have serious economic consequences for organic and other non-GE farmers.

     To make the point about keeping out pollen, Voosen makes a interesting comparison to cattle ranching. “In the eastern part of the United States, traditionally, farmers have been obliged to fence in cattle. In the West, meanwhile, landowners are required to fence out roaming herds. The same distinctions apply to crops. Europe has been busy erecting a complex regulatory apparatus requiring farmers to ‘fence in’ their GM crops with isolation distances and liability funds. With no regulations, the United States has in effect required non-GM farmers to ‘fence out’ GM crops, placing the economic burden on conventional farming.”

  A copy of Judge Jeffrey S. White order in Center for Food Safety, et al. v. Thomas J. Vilsack, et al., is available here.

USDA/APHIS Comment Period for Proposed Rule on Genetically Engineered Organisms

The USDA Animal and Plant Health Inspection Service (APHIS) has asked for comment on its proposal to revise APHIS regulations on the importation, interstate movement, and environmental release of genetically engineered organisms (74 Fed. Reg. 2907 (Jan. 16, 2009)).  APHIS requested comment on the following four issues:

(1) Scope of the regulation and which [Genetically Engineered (“GE”)]  organisms should be regulated;

(2) Incorporation into APHIS regulations of the Plant Protection Act’s noxious weed authority;

(3) Elimination of notification procedure and revision of the permit procedure;

(4) Environmental release permit categories and regulation of GE crops that produce pharmaceutical and industrial compounds.

APHIS is planning for April public meeting(s), but the dates of the meeting(s) are yet to be announced.  APHIS is also extending the comment period for the proposed rule until 60 days after the April meeting(s).

Comments may be sent postal or commercial delivery (two copies) to Docket No. APHIS-2008-0023, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.  Comments may also be submitted on the Federal eRulemaking portal.

Creekstone Farms v. USDA

In a split decision the U.S. Court of Appeals for the D.C. Circuit in Creekstone Farms Premium Beef v. USDA, the majority found that the Virus-Serum-Toxin Act (VSTA) authorizes USDA to prohibit use of a test kit for bovine spongiform encephalopathy (BSE). VSTA authorizes USDA to enact regulations “as may be necessary to prevent the preparation, sale, barter, exchange, or shipment as aforesaid of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, or otherwise to carry out this chapter.”

The court accepted USDA’s interpretation of “analogous products” to include test kits that are used in the diagnosis of disease. Diagnosis of disease is integral to the treatment of disease, so this is not too far of a stretch to include diagnosis as part of treatment. But Creekstone Farms never intended to use the test for the treatment of disease. Creekstone would have tested only already dead animals. Further, BSE is invariably fatal and untreatable. USDA’s argument that Creekstone’s testing would be a form of treatment stretches plausibility. Nonetheless, a diagnostic test that helps control of the spread of a disease might be squeezed into “treatment.”

But the stretching must continue because VSTA applies to products that are used in treatment of domestic animals and are a “worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product.” The agency appears to lacks authority to restrict useful, non-contaminated, non-dangerous, non-harmful products. USDA finds this BSE test kit worthwhile enough to use in its own testing, so it is not clear how this BSE test kit is worthless, contaminated, dangerous, or harmful.

USDA argues, not that the test kits are worthless, but only Creekstone’s proposed use is worthless. Given the young age of most cattle at slaughter and the long incubation period for BSE, USDA argues the test would produce meaningless results. This authority to regulate the use of otherwise acceptable test needs to be pulled from VSTA general empowerment of USDA to enact regulations to, “otherwise carry out” the Act. What if Creekstone wanted to use home pregnancy test kits on its cattle? Would USDA have the authority to ban this use?

In his dissent, Judge Sentelle remained unpersuaded that VSTA grants this “use” authority. Sentelle found USDA “exceeded the bounds of reasonableness” in aggregating power to itself. Sentelle explained, "congressional provision of an expressed authority mandate to accomplish statutory goals does not create for the agency ‘a roving commission’ to achieve those or ‘any other laudable goal,' by means beyond the authority granted in the statute." [Citations omitted.]

This matter has not ended. One count remains to be decided by the district court. Creekstone argues that USDA's refusal to allow Creekstone to purchase BSE test kits to test its own cattle is arbitrary and capricious. USDA offered two reasons for the denial. The agency asserts that this use would not be scientifically sound, and USDA has a mandate to “maintain domestic international confidence in U.S. cattle and beef products.”

However, Creekstone did not want to test to ensure the safety of its beef but, rather, to allow the company export its meat to Japan and Korea. From Judge Sentelle’s dissent, “It seems that the Department’s fear is that Creekstone’s use of the test kits would enable it to provide buyers with a false assurance that the cattle from which its beef is obtained are free of Bovine Spongiform Encephalopathy. However, as I read the record, all Creekstone hopes to do is assure foreign buyers that the beef is as well-tested as would be the case with beef produced in the home countries of those buyers.” The purpose of VSTA is not to prevent false claims, and USDA has other authorities to prevent false claims, as does the Federal Trade Commission.

Granted, USDA has a mandate to maintain domestic international confidence in U.S. cattle and beef products. How USDA finds these reasons within its authority under VSTA is unclear. It will be interesting to see whether either of these reasons can survive the arbitrary and capricious test on the district court’s review.

Hat tip to Jonathan Adler and The Volokh Conspiracy for his insight on this decision.