A federal court in Georgia has called for the prosecutors and defendants in a criminal action arising from the 2009 nationwide Salmonella outbreak linked to the peanut products made by the Blakely, Georgia, Peanut Corp. of America to propose a scheduling order and trial dates between July 7, 2014, and August 2014. United States v. Parnell, No. 13-cr-12 (M.D. Ga., order entered December 11, 2013). The case had been set for trial in February. The court also agreed to review in camera affidavits and other supporting documents “to demonstrate why [the defendants’] defenses are antagonistic and mutually exclusive.” Former Peanut Corp. owner Stewart Parnell has requested that the court sever the proceedings which have been brought jointly against him and several company employees. The court further reserved ruling on pending discovery motions and the government’s motion for a competency hearing as to Stewart Parnell. Issue 507
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According to court records, prosecutors have filed a motion for psychiatric examination as to Stewart Parnell, who is under criminal indictment for actions relating to the 2009 nationwide Salmonella outbreak linked to the peanut products made by the Blakely, Georgia, Peanut Corp. of America plant that Parnell owned. United States v. Parnell, No. 12-cr-12 (M.D. Ga., motion filed December 4, 2013). Information about the criminal charges appears in Issue 472 of this Update. Parnell has filed a motion to sever defendant and counts. The criminal proceedings against him are currently joined to charges against other company employees.
The U.S. Food and Drug Administration (FDA) has issued a request for comments on proposed revisions to its “Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds.” With the aim of helping sponsors design efficacy studies to support the submission of food additive petitions (FAPs) related to preventing Salmonella in food for animals, FDA noted that a revision is necessary because science, technology and FDA policy have changed since the guidance was last revised. Because current guidance addresses only chemical food additives intended to maintain feeds or feed ingredients as Salmonella-negative, the agency intends to expand the scope to address other categories of food additives beyond chemical food additives and to cover all food for animals, including pet food. Among other things, FDA seeks comment on the following questions: (i) what intended technical effects will the agency see in FAPs for anti-Salmonella use of…
A December 6, 2013, hearing will be held before a Federal court in Georgia on pending pretrial motions in a criminal lawsuit filed against former Peanut Corp. of America officials and employees, including owner Stewart Parnell. United States v. Parnell, No. 13-CR-12 (M.D. Ga., November 5, 2013). The company was the source of a nationwide Salmonella outbreak in 2009, and the 76-count indictment charges four individuals with conspiracy, mail and wire fraud, obstruction of justice, and other counts related to the distribution of adulterated and misbranded food. Among the pending motions are requests for the disclosure of government witnesses and release of Brady materials (exculpatory information).
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has announced a final rule intended to bring its import regulations for bovine spongiform encephalopathy (BSE) in line with “internationally-accepted scientific literature and standards set by the World Organization for Animal Health (OIE).” According to a November 1, 2013, press release, the new rule will require APHIS to use OIE criteria and categories to determine BSE risk classification when setting import policy for a particular country. It will also allow APHIS “to conduct its own assessment when deemed necessary, such as when a country is not yet classified by the OIE for BSE risk and requests that APHIS conduct a risk evaluation using criteria equivalent to that used by OIE.” “This action will bring our BSE import regulations in line with international standards, which call for countries to base their trade policies on the actual risk of animals…
The U.S. Food and Drug Administration (FDA) has issued a request for comments concerning a proposed information collection for a Food Safety Survey. Specifically, the agency seeks comment on the following questions: (i) is the information collection necessary and will it provide practical utility; (ii) is the estimate of the burden of the information collection, including the validity of the methodology and assumptions used, accurate; (iii) can the quality, utility and clarity of the information be enhanced; and (iv) how can the burden of the information collection on respondents be minimized. The Food Safety Survey, which the agency notes will contain many of the same questions and topics as previous Food Safety Surveys, will also be updated to explore emerging consumer food safety topics and expand understanding of previously asked topics. New topics to be explored include the increase in listeriosis rates in people older than age 60; consumer understanding of…
The U.S. Food and Drug Administration (FDA) has released a draft of its spice risk report, which calls attention to the most common microbial hazards and filth in imported spices, along with possible sources of contamination. The report, “Pathogens and Filth in Spices,” also evaluates current mitigation techniques, recommends options and identifies research needs and data gaps. According to FDA, a notice about the report will be published in the November 4, 2013, Federal Register. Calling the findings a “wake-up call” to spice producers, FDA revealed that of the products tested between 2007 and 2010, (i) spices are twice as likely to be contaminated as other types of imported food; (ii) 12 percent of spices imported into the United States were contaminated with insect parts, excrement, rodent hair and other materials; (iii) 7 percent of the shipments contained Salmonella; and (iv) spices imported from Mexico and India apparently have the highest rate of contamination.…
Public Health England researchers have reported that the abnormal prion protein (PrP) linked to variant Creutzfeldt-Jakob Disease (vCJD) the human form of bovine spongiform encephalopathy (BSE)—is potentially more prevalent than previously thought, raising concerns about the cross-contamination risks associated with blood, blood products and surgical instruments. Noel Gill, et al., “Prevalent abnormal prion protein in human appendixes after bovine spongiform encephalopathy epizootic: large scale survey,” British Medical Journal, October 2013. After finding that 16 out of 32,411 appendix samples obtained between 2000 and 2012 tested positive for abnormal PrP, the study’s authors estimated an overall prevalence of 493 per million population, nearly double the 237 per million point estimate measured in an earlier survey of appendixes. “Unlike in clinical cases of variant CJD, no particular age group or geographic region was affected, and no susceptible genotype was identified,” according to a concurrent BMJ editorial. The researchers noted, however, the growing discrepancy…
Jensen Farms has filed a lawsuit against the company that hired the food-safety auditor who gave the cantaloupe grower a “superior” rating during a 2011 audit not long before the grower shipped fruit allegedly contaminated with Listeria to a distributor that required the cantaloupe to be certified by the auditor, giving rise to a nationwide outbreak that killed 33 people and hospitalized many others. Jensen Farms v. Primus Group, Inc., No. ___ (Colo. Dist. Ct., filed October 15, 2013). The farm has since ceased operation, and the Jensen brothers have entered guilty pleas to charges of adulteration of food and aiding and abetting. According to the complaint, a Primus auditor indicated in 2010 that the cleaning technology used at the farm could potentially contaminate cantaloupe because it used re-circulating chlorinated water. The 2011 auditor, a different individual, was told about changes to the system made in response to the 2010 concerns,…
Two new studies recently published in the Journal of Infectious Diseases have reportedly identified for the first time in more than 40 years a new strain of Clostridium botulinum, prompting debate over whether the genetic sequences needed to reproduce the toxin should be made available to the public despite concerns that the information could pose a security risk. Jason Barash and Stephen Arnon, “A Novel Strain of Clostridium botulinum That Produces Type B and Type H Botulinum Toxins,” Journal of Infectious Diseases, October 2013. Nir Dover, et al., “Molecular Characterization of a Novel Botulinum Neurotoxin Type H Gene,” Journal of Infectious Diseases, October 2013. According to an October 10, 2013, article in CIDRAP News, the California Department of Public Health researchers who discovered botulinum neurotoxin type H (BoNT/H) using an infant botulism case have declined to release their data until an antitoxin has been developed. They apparently arrived at their decision after…
