The House Energy and Commerce Committee’s report on the 2011 Listeria outbreak that was traced to cantaloupes grown and processed at Jensen Farms in Colorado has identified a number of problems that led to the “deadliest foodborne illness outbreak in over 25 years.” The bipartisan investigation found that a third-party auditing company (i) gave the farm high food-safety marks despite identifying major and minor deficiencies, (ii) did not hold the farm to anything other than baseline industry standards, and (iii) had no procedures in place to require corrective actions. One of the problems that led to the outbreak was the farm’s failure to use an anti-microbial solution in the cantaloupe wash water. Jensen Farms apparently stopped using the solution after consulting with the third-party auditing company in 2010 about ways to enhance its food-safety efforts. In 2011, the farm had adopted an alternative to the hydrocooler it previously used to process…
Tag Archives food safety/FSMA
Congress has approved and President Barack Obama (D) has signed a bipartisan agricultural spending bill (H.R. 2112) that will block or delay regulations aimed at making school lunches healthier. Signed into law on November 18, 2011, the bill will, among other things, prohibit the U.S. Department of Agriculture (USDA) from limiting starchy vegetables, such as potatoes, to two servings a week and will continue to allow two tablespoons of tomato paste to count as a vegetable. It will also require further study of USDA’s long-term sodium reduction requirements that would reduce by half the amount of sodium in school meals over the next 10 years. Although some lawmakers claim that the bill will prevent costly regulations and provide school districts greater flexibility in improving the quality of school meals, critics assert that it will keep schools from serving an array of vegetables while allowing foods such as french fries to remain…
The Denver Post has published an October 30, 2011, investigative report that examines the record of private auditors hired by manufacturers to ensure food safety. According to the article, “Many of the most notorious food-illness outbreaks in the recent years were preceded by glowing private safety audits of the producers, prompting calls for oversight of auditors and forcing grocery store chains to tighten screening of cantaloupes and other foods.” Highlighting several high-profile food contamination cases that allegedly slipped past third-party audits, the article claims that the latest incident involving Listeria-tainted cantaloupe resulted in 28 fatalities even though the supplier received a “superior” safety rating from its private inspector. “I cannot think of one private audit that I’ve ever seen in 20 years that said, ‘These are bad things, fix them,’” confirmed plaintiffs’ attorney Bill Marler. “A private auditor is not going to list a farm’s flaws, tell it to shut…
The Food and Drug Administration (FDA) has issued industry guidance concerning the “administrative detention of human or animal food.” Providing information about FDA’s authority under the Food Safety and Modernization Act to hold adulterated or misbranded food and prevent it from reaching the marketplace, the guidance explains who can approve an administrative detention order, what food may be subject to detention, who receives a copy of the order, and the appeals process. See Federal Register, October 25, 2011.
The Food and Drug Administration (FDA) has issued industry guidance concerning new fee provisions under the Food Safety Modernization Act. The guidance aims to provide answers to common questions about FDA’s plans for implementing the fees in fiscal year 2012. In particular, the guidance addresses such topics as fees for import re-inspections and non-compliance of a recall order, and FDA’s process for requesting fee reductions. FDA will accept comments at any time. See Federal Register, October 6, 2011.
The Food and Drug Administration (FDA) has issued its “Strategic Plan for Regulatory Science,” a document deemed to be the agency’s “blueprint for overhauling the science it uses to develop and evaluate food, medicines, and medical devices.” In a section underscoring the agency’s emphasis on food safety, the document focuses on prevention and risk-based priorities required by the Food Safety Modernization Act. “To effectively implement this new food safety mandate, it is imperative that FDA ensures a strong science infrastructure, clearly identifies its research needs, and collaborates with other public health and research agencies in the [f]ederal government, state government agencies, academia, and private industry,” states the document, which details FDA’s Regulatory Science Initiative outlined in October 2010. Regarding food science, FDA plans to (i) “[e]stablish and implement centralized planning and performance measurement processes,” (ii) “[i]mprove information sharing internally and externally,” (iii) “[m]aintain mission critical science capabilities,” and (iv) “[c]ultivate…
The Food and Drug Administration (FDA) has issued a notice and request for comments about fiscal year 2012 fees under the Food Safety Modernization Act (FSMA). The fee rates, intended to “capture 100 percent of the costs of each activity,” will be assessed for facility reinspections, recalls and importer reinspections. If no foreign travel is required, the rate will be $224 per hour, and if foreign travel is required, the fee increases to $335 per hour. While a separate schedule has not been established for small businesses, FDA indicates that it will waive the fees “in limited cases . . . based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors.” FDA has also established a docket “to obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as…
“The big question is this: How do we get the safest and most ethical food system possible while adequately feeding ourselves?,” asks New York Times columnist Mark Bittman in this latest opinion piece supporting “a massive overhaul of the food system.” Discussing recent E. coli outbreaks in Europe, Bittman concedes that the controversial process known as irradiation “could be a useful tool” in controlling bacteria and other foodborne illnesses, but warns that it should not be viewed as a panacea or replacement for other measures. “The answer will come in steps,” he writes. “[B]etter regulation and inspection of food production; stricter labor laws; more rigorous testing for pathogens, to name just a few— and eventually those steps may lead to a point where irradiation is unnecessary.” Bittman urges lawmakers to adequately fund the Food and Drug Administration’s Food Safety Modernization Act, even while citing “the ironies” inherent in a system…
The American Bakers Association and a number of other industry trade associations have submitted a citizen petition to the Food and Drug Administration (FDA) seeking regulations that would exempt those businesses engaged in storing packaged foods from hazard analysis and prevention controls applicable to food producers and processors. The petition notes that under the Food Safety Modernization Act (FSMA) Congress allowed FDA to implement its food safety provisions “in a manner that acknowledges the difference in risk posed by various types of operations.” Claiming that “storage facilities themselves pose a very limited, if any, food safety risk,” the petition notes that any potential hazards in warehouses are already addressed through existing good manufacturing practices governing warehousing and distribution facilities. The petitioners, including the Grocery Manufacturers Association, International Bottled Water Association, and Snack Food Association, seek a rule that would state, “A facility that is engaged solely in the storage, holding,…
A federal court in California has denied Safeway, Inc.’s motion to dismiss or stay proceedings alleging that it has an obligation to use information in its loyalty card customer database to provide email notice about produce recalls ordered by the Food and Drug Administration (FDA) or U.S. Department of Agriculture. Hensley-Maclean v. Safeway, Inc., No. 11-1230 (N.D. Cal., order entered June 13, 2011). Additional details about the case, which was first filed in state court, appear in Issue 380 of this Update. The grocery company argued that the “primary jurisdiction doctrine” or “equitable abstention” required the court to dismiss or stay the litigation “until and unless regulatory agencies have had the opportunity to consider and adopt appropriate rules governing the obligations a grocery store has with respect to providing its customers notice of such recalls.” According to Safeway, the Food Safety Modernization Act requires FDA to develop notice guidelines by…
