By failing to adequately fund and implement the Food Safety Modernization Act (FSMA), the “Obama administration and Congress have all but squandered an opportunity to give the anemic Food and Drug Administration, which is responsible for the safety of 80 percent of the nation’s food supply, a level of oversight the public long assumed it had,” according to a July 14, 2015, Politico investigation. The lengthy article details various delays in implementing the law and serious outbreaks of foodborne illnesses that might have been prevented had FDA been given the financial resources for inspections and other food-safety initiatives. Issue 572
Tag Archives food safety/FSMA
In a recent Associated Press (AP) interview, U.S. Associate Attorney General Stuart Delery warns that the Department of Justice (DOJ) will pursue criminal penalties against companies that sell poisoned food. AP cites the recent prosecution of Peanut Corp. of America executives along with actions against the producers of tainted cantaloupe and eggs as evidence of the federal government’s increased focus on criminal enforcement of food safety laws. Plaintiffs’ attorney Bill Marler reportedly told the news organization that the DOJ’s actions were especially notable because the company executives charged in the prosecutions often did not know that their food products were tainted. “We have made a priority holding individuals and companies responsible when they fail to live up to their obligations that they have to protect the safety of the food that all of us eat,” Delery said. “The criminal prosecutions we bring should stand as a stark reminder of the…
U.S. Sens. Dick Durbin (D-Ill.), Dianne Feinstein (D-Calif.) and Kirsten Gillibrand (D-N.Y.) are seeking a study from the Government Accountability Office (GAO) about the practicality of a single federal agency charged with oversight for food safety. “Given concerns about the fragmented federal food safety system in the United States and potential lessons to be learned from consolidation efforts in other countries,” the senators wrote in a June 23, 2015, letter, “we request GAO’s assistance in addressing the following questions: (1) What alternative organizational structures have been identified to streamline and consolidate the U.S. food safety system? (2) What are the costs and benefits associated with each alternative and what implementation challenges exist, if any? [and] (3) What lessons learned and best practices can be gleaned from other countries’ efforts to consolidate their food safety functions and systems?” In January 2015, the senators reintroduced with Rep. Rosa DeLauro (D-Conn.) legislation that would…
The U.S. Food and Drug Administration (FDA) has issued draft guidance about the implementation of mandatory food recall provisions under the Food Safety Modernization Act (FMSA). The guidance provides answers to common questions such as “What evidence might FDA consider when deciding to move forward with a mandatory food recall under Section 423 of the Federal Food, Drug, and Cosmetic Act?” Interested parties may submit comments to the Division of Dockets Management until July 6, 2015. See Federal Register, May 7, 2015. Issue 565
Attorneys in the U.S. Department of Justice and U.S. Department of Health and Human Services have filed a lawsuit against Wholesome Soy Products to permanently enjoin the company, its owner and manager from causing food to become adulterated under the Federal Food, Drug, and Cosmetic Act (FDCA) after government agencies allegedly linked the company’s facilities to a 2014 outbreak of Listeria in Michigan and Illinois. United States v. Wholesome Soy Prods., Inc., No. 15-2974 (N.D. Ill., filed April 3, 2015). Wholesome Soy manufactured and sold mung bean and soybean sprouts until November 2014, when the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA) and state agencies allegedly traced incidents of Listeria infections observed in five people to the Wholesome Soy facility. An FDA laboratory allegedly found Listeria in 28 samples—including two from mung bean sprouts—taken during a September 2014 inspection of Wholesome Soy’s plant and…
To ease producer burdens under the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) has revised four proposed rules related to produce safety; preventive controls for human food and animal food; and the foreign supplier verification program. After receiving feedback from consumers and industry stakeholders, the agency has (i) updated water quality testing provisions; (ii) exempted farms with less than $25,000 in sales from produce-safety rules; (iii) addressed the use of spent grains in animal food by clarifying that brewers and distillers subject to the human-food rules do not need to comply with all animal-food rules; and (iv) granted importers more flexibility under the proposed foreign-supplier verification program “to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.” FDA has requested comments on the proposed changes by December 15, 2014. “Ensuring a safe and high-quality food supply is one of the FDA’s…
The Food and Drug Administration (FDA) is reportedly taking measures to bolster intra-agency program processes based on a comprehensive review of the scientific capacity and management of the Chemical Safety Program across the Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM). FDA plans to address improvements in the principal categories of science, communication and collaboration, and training and expertise. Among other things, the agency intends to (i) update the agency’s Toxicological Principles for the Safety Assessment of Food Ingredients (Redbook); (ii) establish consistent methodologies for safety and risk assessments within and across CFSAN offices and between CFSAN and CVM; (iii) increase collaboration on emerging issues with other federal agencies; and (iv) create an experts database to help identify potential collaborators both inside and outside the agency. See FDA Constituent Update, August 28, 2014. Issue 537
The European Food Safety Authority’s (EFSA’s) Panel on Biological Hazards (BIOHAZ) has issued a scientific opinion on the risk posed by Salmonella and norovirus in fresh and frozen berries. According to BIOHAZ, which reviewed the limited data pertaining to the prevalence of these foodborne pathogens in berries, the risk factors for contamination are likely to include environmental conditions, contact with animal reservoirs and insufficiently treated compost, the use of contaminated water for irrigation or chemical applications, and cross-contamination by harvesters, food handlers or equipment. To mitigate these risks, BIOHAZ urges primary producers to implement Hazard Analysis and Critical Control Points (HACCP) systems as well as Good Agricultural Practices, Good Hygiene Practices and Good Manufacturing Practices (GMP). More specifically, the scientific opinion identifies Norovirus in frozen raspberries and strawberries as “an emerging public health risk,” stressing the need for additional data to develop microbiological criteria for improved control of norovirus in…
The U.S. Food and Drug Administration (FDA) has released its Food Code Reference System (FCRS), a searchable database that provides information for industry about FDA’s positions and responses to questions related to the FDA Food Code. With an aim “to promote nationwide consistency and increase transparency about the Food Code,” FCRS contains entries that clarify issues such as (i) storing foods that require temperature control for safety; (ii) food establishment design and food equipment cleaning; (iii) bare hand contact with ready-to-eat foods; and (iv) preventing food contamination. FDA plans to add entries that are “important to the uniform application of the Food Code and that may have implications across all jurisdictions that regulate food establishments.” These entries will reflect questions previously answered by FDA as well as responses to future inquires that FDA receives. The Retail Food Protection Team in FDA’s Center for Food Safety and Applied Nutrition (CFSAN) will…
The U.S. Food and Drug Administration (FDA) has issued an advance notice of proposed rulemaking under the Food Safety Modernization Act (FSMA) that seeks information to help the agency “implement and enforce” amendments to the reportable food registry (RFR) provisions of the Federal Food, Drug, and Cosmetic Act. Among other things, the new provisions permit FDA to (i) require that parties submit to FDA “consumer-oriented” information regarding certain reportable foods—defined as foods for “which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or animals”; (ii) use such information to create consumer notification summaries for the agency’s Website; and (iii) obligate certain grocery stores that sell reportable food to display the notification summaries. FDA has requested input from the food industry, consumer organizations and other parties on certain topics, including (i) “what information should be required in…
