FDA Launches Two Food Safety Initiatives

The U.S. Food and Drug Administration has launched two Internet-based initiatives that may be noteworthy for MassTortDefense readers involved in food safety issues.

First, the FDA has launched an Internet-based registry to track patterns in contaminated food.  The site, explained here, is a result of 2007 legislation requiring food facilities to report potentially dangerous products. Food industry officials are required to use the Reportable Food Registry to alert the FDA when they discover a risk that  their products might injure people or animals, the agency stated last week. By fostering real-time submission to the FDA of information on food safety hazards, the registry is supposed to enhance the agency’s ability to act quickly to prevent food-borne illness. The goal is to catch the problem before people get sick. 

Facilities that manufacture, process, or hold food for consumption in the U.S. must now tell the FDA within 24 hours if they find a “reasonable probability” that an article of food will cause severe health problems or death to a person or an animal. The reporting requirement, which applies to all foods and animal feed regulated by the FDA, does not reach infant formula and dietary supplements.

Any person who has to submit registration information to the FDA for a food facility that
manufactures, processes, packs, or holds food for human or animal consumption is deemed a “responsible party” and must follow the reporting requirement. A responsible party also must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party. 

The registry's proposal drew criticism from some industries, and they in fact had asked the FDA last month to extend the effective date for reporting. For example, national organizations representing the grain, feed, grain processing and pet food industries said that, at the very least, the FDA should exercise enforcement discretion in order to provide an appropriate phase-in period. FDA did not do so.

The launch of the FDA registry comes just as Congress is considering a new food safety bill that would give the FDA more funding and greater authority to order recalls of products. The House passed a food safety bill in the summer, and the Senate is expected to take up the issue later this fall.

At the same time, the administration is rolling out a new Web site designed to streamline food safety information for the public. Health and Human Services Secretary Sebelius announced the new Web site  last week. The site is a joint effort among HHS, the Department of Agriculture and the FDA.

The site will put food-related information from all federal agencies in one place.  It includes sections on how to "Keep Food Safe"; what to do in the case of suspected "Food Poisoning"; a section for industry relating to "Inspections & Compliance"; as well as food news, agency events (such as workshops, meetings, and conferences) for FDA, CDC, USDA; and educational materials on food safety.  Of particular interest to our readers may be the links to agency speeches and presentations, communications to Congress, and Congressional testimonies.


D.C. Circuit Upholds USDA Ban On Additional "Mad Cow" Testing-- So Far

The U.S. Court of Appeals for the District of Columbia Circuit has overturned the ruling of a trial court, and has held that the federal government can prohibit meatpackers from doing additional testing of their animals for "mad cow" disease. Creekstone Farms Premium Beef, L.L.C. v. Department of Agriculture, 2008 WL 3980533 (D.C. Cir. 2008).

The dispute arose between the Agriculture Department, which tests a statistical sample of cows for the potentially deadly disease, and a Kansas meatpacker, Creekstone Farms Premium Beef, which wants to test all of its animals.

Bovine Spongiform Encephalopathy (BSE) is an invariably fatal neurological disease that causes degeneration of the cow's central nervous system. BSE occurs when healthy cattle are fed the remains of an animal infected with abnormally formed prions. As abnormal prions accumulate within the brain cells, they cause the cells to rupture, resulting in a loss of coordination and ultimately the death of the animal. Prions that cause BSE in cattle can cause a similar disease in humans known as variant Cruetzfeldt-Jakob Disease (vCJD). Since 1986, approximately 190 people - 95% of whom resided in the United Kingdom - have died as a result of confirmed cases of vCJD. Some scientists believe humans can contract vCJD by consuming BSE-contaminated beef or beef products.

BSE was first diagnosed in the United Kingdom in 1986. Since then, more than 189,000 confirmed cases of BSE in cattle worldwide have been reported. While almost all of the cases (95%) have occurred in the United Kingdom, BSE has been found in cattle raised in at least twenty-five other countries. In 1989, USDA banned the importation of animal remains from countries with known BSE-infected cattle. Only three BSE-infected cows have been found in the United States. The first was reported in December, 2003 in a Canadian-born cow in Washington State. Two more BSE-infected cattle were found after that, one in Texas in June, 2005, and one in Alabama in March, 2006. In July, 2006, USDA announced that in light of “the extremely low prevalence of the disease” in the U.S ., it intended to test a sampling of approximately 40,000 per year, about 1% of the total number of cattle slaughtered in the United States.

The Dispute

In December, 2003, many countries began to ban or severely limit importation of U.S. beef because bovine spongiform encephalopathy (BSE) -mad cow disease- had been found in that one cow in Washington State. To counter the fears of beef importers as well as domestic consumers, plaintiff Creekstone developed a plan, it asserted, to test for BSE each of the approximately 300,000 cattle it slaughters each year. The United States Department of Agriculture (USDA), however, asserting authority under the Virus-Serum-Toxin Act, denied Creekstone's request to purchase or use BSE test kits. Specifically, Creekstone sought to purchase rapid BSE test kits but the importer informed Creekstone that it could not sell Creekstone the kits without USDA authorization. USDA denied Creekstone's requests for permission.

Plaintiff sued, and the trial the court concluded that USDA cannot regulate BSE testing because, while the regulations allow USDA control of the diagnosis and treatment of cows, the test kit cannot be used in the treatment of domestic animals. The court reasoned that, because there is no known cure for BSE and because testing can be done only post-mortem, rapid BSE test kits are not used for “treatment.”

The Court of Appeals disagreed. The regulations define “treatment” as including the prevention, diagnosis, management, and cure of diseases of animals. The rapid BSE test kit need fulfill only one of the functions. Plainly, rapid BSE testing is used to diagnose the disease. Moreover, rapid BSE testing plays a valuable role in preventing and managing the spread of BSE. It allows USDA to identify and destroy the remains of an infected cow, trace the spread of the disease, and evaluate the success of its disease management measures. Thus, while there is no way to “treat” or cure the dead cow if the test is positive, the test kit nonetheless plays an important diagnostic role. Moreover, the USDA explained that universal testing is not meaningful because, given BSE's long incubation period and the relatively young age of most cattle at slaughter, it would not produce meaningful results. In contrast, the agency found efficacy of BSE testing when used on high-risk cattle as part of a statistically and epidemiologically valid surveillance plan.

The concurring opinion stressed that the Department's interpretation allowing it to restrict import permits based on intended use of a biological product is entitled to deference under Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984). 

Summary judgment vacated, and plaintiff to have an opportunity to go forward with its case on remand, subject to the ruling.