Del Monte Fresh Produce has reportedly informed Oregon Public Health and state Senior Epidemiologist William Keene that it will not act on its notice to sue over their identification of the company’s imported cantaloupes as the source of a 2011 Salmonella outbreak. Additional details about the litigation threat appear in Issue 408 of this Update. While a spokesperson refused to comment on the company’s action, its letter apparently indicated that the withdrawal was “a show of good faith” in its food safety discussions with the state; it is seeking a meeting with state food safety scientists. Del Monte Fresh Produce also sued the Food and Drug Administration (FDA), claiming that the agency lacked an adequate factual basis to conclude that the company’s Guatemalan cantaloupe supplier was the source of the contamination. The company sought to lift FDA’s import alert which prohibited it from importing from its Guatemalan source without proving the…
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A company that insured Basic Food Flavors Inc. has asked a court to approve its settlement in a coverage dispute concerning a 2010 Salmonella outbreak involving hydrolyzed vegetable protein, a flavorings ingredient used in processed foods. Employers Fire Ins. Co. v. Basic Food Flavors Inc., 10-1109 (D. Nev., motion to approve settlement filed March 21, 2012). The ensuing recall apparently affected more than 100 of Basic Food’s customers, in addition to downstream suppliers, distributors and retailers. Under the agreement, the insurance company agreed to pay its coverage limits of $11 million. According to a news source, a neutral administrator has approved more than $34 million in claims against Basic Food. See Law 360, March 22, 2012.
A federal court in South Carolina has dismissed three of four claims in a lawsuit filed by a family farming operation that claims the Food and Drug Administration’s (FDA’s) 2008 tomato recall, which later proved unnecessary as the agency conceded that tomatoes were not the source of the Salmonella contamination, caused the farm substantial economic harm. Seaside Farm, Inc. v. United States, No. 11-1199 (D.S.C., decided March 6, 2012). Further details about the litigation appear in Issue 395 of this Update. The court dismissed the plaintiff’s Takings Clause claim, the claim that FDA violated the South Carolina Unfair Trade Practices Act and the defamation claim. The plaintiff’s negligence claim will, however, proceed. While the court suggested that this may actually be a claim for defamation and thus may also be subject to dismissal under the Federal Tort Claims Act, because the defendant did not seek to dismiss on this ground, the court declined…
The Food and Drug Administration (FDA) has announced the availability of industry guidance concerning drugs for veterinary care. The guidance provides “recommendations on what documentation to submit to support the CMC [Chemistry, Manufacturing, and Controls] information for fermentation-derived intermediates, drug substances, and related drug products for veterinary medicinal use.” Noting that a variety of products are manufactured from fermentation processes, such as “competitive exclusion products” that consist of one or more microorganisms intended to prevent harmful bacteria like Salmonella from colonizing, FDA has requested comments on the guidance at any time. See Federal Register, March 8, 2012.
The Food and Drug Administration (FDA) has released industry guidance addressing the testing procedures for Salmonella species “in human foods and direct-human-contact animal foods.” Applicable to firms that manufacture, process, pack, or hold these products for distribution to consumers, institutions or food processors, the guidance also discusses the interpretation of test results when the presence of Salmonella “in the food may render the food injurious to human health.” The guidance excludes egg producers and others covered under different FDA food safety rules. The agency will accept comments at any time. See Federal Register, March 8, 2012.
A federal court in South Carolina has reportedly determined that a tomato grower seeking damages from the U.S. Food and Drug Administration (FDA) allegedly caused by a 2008 tomato recall that followed a Salmonella outbreak which was ultimately found not to be linked to contaminated tomatoes, may pursue negligence claims against the agency. Williams Farms Produce Sales, Inc. v. United States, No. 11-01399 (D.S.C., order entered February 23, 2012). Further details about the case appear in Issue 398 of this Update. The court has apparently dismissed claims of defamation, slander of title, product/commercial disparagement, unconstitutional taking, and violation of unfair trade practices law. See Law360, February 23, 2012.
A federal court in the District of Columbia has determined that the U.S. Department of Agriculture (USDA) had the authority to and properly promulgated a rule “requiring that almonds produced domestically be pasteurized or chemically treated against bacteria.” Koretoff v. Vilsack, No. 08-1558 (D.D.C., decided January 18, 2012). So ruling, the court granted USDA’s motion for summary judgment. Further information about the challenge brought by U.S. almond growers appears in Issue 274 of this Update. The almond rule was adopted in response to Salmonella outbreaks traced to raw almonds in 2001 and 2004. USDA adopted it under the authority of the Agricultural Marketing Agreement Act of 1937 and the California Almond Marketing Order (Almond Order), promulgated in 1950. At issue in the dispute between the U.S. almond growers and USDA was whether safety regulations are encompassed by the law’s use of the term “quality,” over which USDA specifically has regulatory…
The Office of Inspector General (IG) of the U.S. Department of Health and Human Services has issued a report that “identified significant weaknesses in FDA’s [the Food and Drug Administration’s] oversight” of its contracts for state inspections of food facilities. In recent years, FDA has increasingly shifted to the states its responsibility for conducting inspections, and has apparently “failed to ensure [in eight states] that the required number of inspections was completed,” “did not ensure that all State inspections were properly classified and that all violations were remedied,” and “failed to complete the required number of audits for one-third of the States and did not always follow up on systemic problems identified.” Based on an analysis of FDA inspection data and interviews with agency officials, the report, titled “Vulnerabilities in FDA’s Oversight of State Food Facility Inspections,” opens by noting that annually “128,000 Americans are hospitalized and 3,000 die after…
Attorneys involved in the settlement of injury claims linked to Salmonella-contaminated eggs traced to Wright County Egg in Iowa have reportedly told the Associated Press that the first checks, issued by the egg producer’s insurer, are on their way to the first of dozens of individuals sickened during the 2010 outbreak. Among the first wave of legal settlements are six-figure checks issued on behalf of several children. Although most of the settlement’s terms are confidential, a federal judge in Iowa apparently approved deals in open court on November 10, 2011, totaling $366,000 for three children residing in California, Iowa and Texas. Because they were hospitalized, they are receiving higher amounts than those not as seriously stricken. See MSNBC. com, November 16, 2011.
The Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) has issued an October 24, 2011, memorandum calling for nationwide testing of pet food “to determine the prevalence of Salmonella” and remove contaminated samples from commerce. According to CVM, regulators are concerned about the transmission of “pathogenic and antibiotic-resistant bacteria to humans and other animals,” as well as the risk that Salmonella-tainted pet food, pet treats and supplements for pets could infect consumers in their homes, where products “are likely to be directly handled or ingested by humans.” CVM has directed investigators to collect and submit non-canned pet food, treats and supplements for analysis, which aims to identify “the serotype, genetic fingerprint, and antimicrobial susceptibilities of each Salmonella found in samples.” The agency will also use these samples for “research purposes” and “providing surveillance information on microbes other than Salmonella.” “Salmonella-contaminated pet foods, pet treats and supplements for pets…
