The U.S. Food and Drug Administration (FDA) has announced a final rule setting standards for manufacturers of infant formula. With a compliance date of September 8, 2014, the final rule includes (i) “current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter”; (ii) “a requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth”; and (iii) “a requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.” Although many companies have already adopted these standards on a voluntary basis, the final rule creates federally enforceable requirements for powdered, liquid concentrate and ready-to-feed formulas. “FDA does not approve infant formulas before they can be marketed,” notes the agency in a June 9, 2014, press release. “However, all formulas marketed…
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As anticipated, Quality Egg LLC and its former owners, Austin “Jack” DeCoster and his son Peter, have entered guilty pleas to charges of introducing adulterated food into interstate commerce. Additional information about the plea agreement appears in Issue 524 of this Update. They admitted that the company’s shell eggs, shipped to buyers in states throughout the country, contained Salmonella in 2010. As part of the plea agreement, the company reportedly agreed to pay a $6.8 million fine. The DeCosters, who will remain free on bail pending sentencing, face a maximum sentence of up to one year in prison or five years’ probation. Sentencing has not yet been scheduled. See USA Today, June 3, 2014. Issue 525
The Center for Science in the Public Interest (CSPI) has filed a complaint against the U.S. Department of Agriculture and Food Safety and Inspection Service, seeking a declaration that the agencies have unreasonably delayed taking action on its May 2011 petition requesting that certain strains of antibiotic-resistant (ABR) Salmonella in ground meat and poultry be declared adulterants. CSPI v. Vilsack, No. 14-895 (D.D.C., filed May 28, 2014). Details about CSPI’s petition appear in Issue 396 of this Update. According to the nutrition and health advocacy organization, if these pathogens are declared adulterants, affected meat and poultry products would be barred from entering commerce, and the action “would also confirm the agency’s authority to request without evidence of illness that a company recall products containing ABR Salmonella, or—in the absence of a company’s voluntary compliance—to detain and seize those products.” The complaint refers to a number of Salmonella outbreaks, some involving…
Stewart Parnell, former president of the Peanut Corp. of America (PCA), linked to a 2008-2009 nationwide Salmonella outbreak that allegedly killed nine who consumed products made with the company’s tainted peanut paste and injured some 700 others, has filed a motion asking the court to exclude “all evidence related to any alleged illness or death” during his criminal trial. United States v. Parnell, No. 13-cr 12 (M.D. Ga., motion filed May 20, 2014). Observing that the government’s pleaded harm “consists of monetary harm to the customers and individuals named” and that the entire case is “premised on the alleged wrongful conduct of obtaining money by false pretenses,” Parnell argues that victim-impact evidence is irrelevant and would be highly prejudicial. In this regard, he states, “[T]he only purpose for introducing evidence of salmonella-related illness and death is to inflame the jury in an effort to suggest a decision on an improper basis.”…
Federal prosecutors have reportedly filed criminal charges against Iowa-based Quality Egg LLC and two former company executives—Austin “Jack” DeCoster and his son Peter—over a 2010 Salmonella outbreak that sickened thousands across the country and resulted in the recall of some 550 million eggs. United States v. Quality Egg, LLC, No. 14-cr-3024 (N.D. Iowa, filed May 21, 2014). The charging document, which brings two felony counts of introducing adulterated food into interstate commerce against the company and related misdemeanor charges against the DeCosters, alleges that the company sold tainted eggs from early 2010 until the August recall. According to news sources, the DeCosters are expected to enter guilty pleas on June 3, 2014, as part of a plea agreement that ends the four-year investigation. The charging document alleges that the company sold products with labels making “the eggs appear to be not as old as they actually were” from 2006 to 2010,…
Researchers at Penn State University’s College of Agricultural Sciences have purportedly found that edible films made from pullulan—a transparent polymer produced by the fungus Aureobasidium pulluns, silver nanoparticles, zinc oxide, and oregano and rosemary essential oils—can inhibit foodborne pathogens on meat products. Mohamed K. Morsy, et al., “Incorporation of Essential Oils and Nanoparticles in Pullulan Films to Control Foodborne Pathogens on Meat and Poultry Products,” Journal of Food Science, April 2014. Observing that the films inhibited the growth of four pathogens: Staphylococcus aureus, Salmonella Typhimurium, Listeria monocytogenes, and E. coli O157:H7—to varying degrees, the researchers concluded that they could form “the basis of a useful packaging tool to improve the safety of meat products.” According to Penn State University Food Science Professor Catherine Cutter, who co-authored the study, the edible films are a “novel but effective way” to deliver antimicrobial agents to meats because the bacteria-killing action lasts longer than the liquid applications traditionally used. “The results from…
Samuel Lightsey, who formerly managed the Peanut Corp. of America, which was implicated in a 2008-2009 nationwide Salmonella outbreak, has entered a guilty plea to six of 76 criminal charges, including conspiracy, mail and wire fraud, obstruction of justice, and other counts related to the distribution of adulterated or misbranded food. U.S. v. Lightsey, No. 13-CR-12 (M.D. Ga., Albany Div., plea entered May 7, 2014). Facing a potential sentence of six years in prison, Lightsey has agreed to cooperate with the prosecution. The outbreak sickened more than 700 who consumed products containing tainted peanut paste, and at least nine died. According to the plea agreement, in September 2008, Lightsey and others shipped a lot of peanut paste from the company’s Blakely, Georgia, facility “without ever having submitted a sample from said lot to a laboratory for microbiological testing.” This food was misbranded because it was accompanied by a document containing…
A federal court in Georgia has denied a motion to sever the criminal charges filed against the former owner of the Peanut Corp. of America, linked to a 2009 nationwide Salmonella outbreak, from charges filed against other company employees. United States v. Parnell, No. 13-cr-12 (M.D. Ga., order entered April 24, 2014). Information about a hearing conducted to assess the reliability of the defendant’s proffered expert—retained to testify about Stewart Parnell’s purported Attention Deficit Hyperactivity Disorder— appears in Issue 517 of this Update. The court has also continued an April 28 status conference in light of a previous ruling rescheduling the trial. Issue 521
A federal court in Georgia presiding over a criminal action against the owner and employees of the now-defunct Peanut Corp. of America, purportedly involved in a 2009 nationwide Salmonella outbreak, conducted a hearing on March 13, 2014, to determine whether the expert testimony proffered as to owner Stewart Parnell’s ability to form the intent to commit the alleged crimes is admissible under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). According to defense expert Joseph Conley, a clinical psychologist, Parnell has an Attention Deficit Hyperactivity Disorder (ADHD) condition. Defense counsel claims that Conley’s testimony will show that Parnell did not commit the alleged crimes because he did not factually acquire the knowledge necessary to form an intent about the actions the government has alleged. Conley would testify that Parnell’s ADHD is so severe that he likely never read, nor understood the significance of, many of the emails on…
An unopposed motion for preliminary approval of a class-action settlement has been filed in a federal court in New York to resolve the claims of those who allegedly purchased Salmonella-contaminated pet food that was subject to a nationwide recall and purportedly linked to infections in people and animals. Marciano v. Schell & Kampeter, Inc., No. 12-2708 (E.D.N.Y., motion filed January 28, 2014. If approved, the settlement would provide $2 million cash to three subclasses of claimants: those who purchased but never used the recalled products, those who purchased and used the products and “sustained economic damages as a result of injury or death to animals from their consumption of recalled products,“ and those who purchased the products subject to recall and fully used them “with no resultant ill effects.” Under the agreement, the defendants would also continue to use improved quality control procedures for three years. Issue 511
