Senator Patty Murray (D-WA) wants answers on alleged FDA food safety failures after a report in Politico listed problems with that agency. Senator Murray is Chair of the Senate Health, Education, Labor, and Pensions Committee. A letter was sent to FDA Commissioner Robert M Califf, asking for answers and immediate action. The Politico report was based on more than 50 interviews with experts and former officials and found that the FDA is more focused on regulating and overseeing drugs and other medical products than food. For instance, FDA commissioners rarely have experience with food issues, but are usually medical doctors. The report lists deadly food poisoning outbreaks and the recalls associated with the contaminated foods, starkly outlining how long it can take to issue a recall … [Read more...]
FDA Proposes Agricultural Water Safety Rule For Use on Produce
There have been multiple E. coli outbreaks linked to fresh produce, especially leafy greens such as romaine lettuce, in the past few years. In several of those outbreaks, agricultural water has been implicated as the source of that pathogen. So the FDA has proposed a new agricultural water safety rule for use on produce. The rule would require farms to conduct comprehensive assessments that will help them identify and mitigate hazards in water that is used to grow produce. This is the latest step in the implementation of the Food Safety Modernization Act (FSMA) of 2011. This proposed rule will replace some of the existing requirements for agricultural water in the Produce Safety Rule. Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response said in a statement, "There … [Read more...]
FDA Proposes New Traceability Rule For Food Manufacturers
The FDA is proposing a new traceability rule for food manufacturers, as well as those who process, pack or hold foods on the Food Traceability List to help identify recipients of those foods quickly to help mitigate foodborne illness outbreaks. In the past few years, the government has blamed their inability to find the sources of foods that have caused outbreaks on traceability issues. This rule would be part of the Food Safety Modernization Act of 2011 (FSMA). The proposed rule is called Requirements for Additional Traceability Records for Certain Foods. It is a key component of the FDA's New Era of Smarter Food Safety Blueprint. The comments periods for the proposed rule and information collection provisions have been extended until February 22, 2021. The rule would be a … [Read more...]
Center For Food Safety Forces FDA to Designate High Risk Foods
The Center for Food Safety (CFS) has forced the FDA to complete the high risk food designations and reporting requirements that were part of the 2011 Food Safety Modernization Act (FSMA). CFS filed a lawsuit against the FDA in October 2018 for delaying those requirements. Now, the FDA must designate "high risk" foods by September 2020 and establish the reporting requirements for those foods by November 2022. The settlement was decided in the United States District Court for the Northern District of California. Ryan Talbott, CFS staff attorney, said in a statement, "This is a major victory for public health. FDA has sat on its hands for years, neglecting to make these high-risk designations, while outbreaks caused by Salmonella, E. coli, and other pathogens have sicken and killed … [Read more...]
New Dates For Implementing Agricultural Water Produce Safety
FDA's Commissioner Dr. Scott Gottlieb and Deputy Commissioner Frank Yiannas have addressed advancing new tools and science for produce safety via agricultural water, and have set new dates for implementation. The two E. coli O157:H7 outbreaks that were linked to romaine lettuce in 2018 were allegedly caused by contaminated agricultural water. In early 2018, 210 people were sickened in an E. coli O157:H7 outbreak linked to romaine lettuce grown in the Yuma, Arizona region of the country. Ninety-six people were hospitalized, and 27 developed hemolytic uremic syndrome (HUS), which can cause kidney failure. Five people died. This outbreak was the largest of its kind since 2006. The outbreak strain was found in canal water in the area. And in late 2018, romaine lettuce grown in … [Read more...]
Delay in Produce Safety Rule Agricultural Water Requirements Worries Advocates
Two groups focused on food safety are concerned about the government's decision to extend compliance dates for Produce Safety Rule agricultural water requirements in the Food Safety Modernization Act. The Center for Science in the Public Interest and Center for Food Safety are worried that delaying this enforcement would cause more than 700,000 cases in foodborne illness. The Produce Safety Rule is intended to make fresh fruits and vegetables safer to eat. Most food poisoning outbreaks are caused by these types of products. And one of the ways they can become contaminated is with animal feces in agricultural water runoff. The rule has provisions that require microbial testing of water for E. coli, a pathogenic bacteria that is often found in the feces of ruminant animals. This is … [Read more...]
Is That Really FDA-Approved?
When you see the words "FDA Approved" on a product, what does that mean? The FDA is a government agency that is responsible for protecting the public health. It regulates human drugs, biologics, animal drugs, medical devices, tobacco products, food, cosmetics, and electronic products that emit radiation. Not all of those products are reviewed for safety and effectiveness by the FDA before thy are marketed. FDA enforcement efforts often focus on products that are already available to consumers. The FDA can act when safety issues and problems arise. The FDA does not approve companies, health care facilities, labs, or manufacturers. Owners and operators of domestic or foreign food and drug companies must register their facilities with the FDA. The FDA approves new drugs and … [Read more...]
FDA Extends FSMA Compliance Dates
The FDA is setting the first major compliance dates for the Food Safety Modernization Act of 2011 for large food facilities. The agency also issued a final rule that "extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules." The final rule addresses technical issues and aligns compliance dates across the four rules. Human food companies, other than small and very small businesses, need to come into compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule by September 19, 2016. This rule creates new requirements for the production of human food in three ways. First, certain domestic and foreign facilities must implement hazard analysis and risk-based preventive … [Read more...]
FDA Issues Final Food Defense Regulation
The FDA released the Food Safety Modernization Act (FSMA) final rule for mitigation strategies to protect food against intentional adulteration last week. This rule is intended to prevent public harm by requiring companies in the U.S. and abroad to take steps to prevent adulteration of the food supply. These facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination. The facilities must also establish food defense monitoring procedures and corrective actions, verify that the system is working, and ensure that personnel assigned to these areas receive adequate training and maintain records as required by the government. Before 1982, most food and drug products did not have tamper-proof … [Read more...]
OSHA Issues Rules for Retaliation Complaints Under FSMA
The Occupational Safety and Health Administration (OSHA) today published a final rule establishing procedures for retaliation complaints under the Food Safety Modernization Act (FSMA). This part of FSMA, which was signed into law by President Obama in January 2011, protects employees who "blow the whistle" about potential violations of the Food, Drug, and Cosmetic Act from retaliation by employers. Assistant Secretary of Labor for OSHA Dr. David Michaels said in a statement, "food industry workers must never be silenced by the threat of losing their jobs when their safety or the safety of the public is at stake. This rule underscores the agency's commitment to protect the rights of workers who report illegal activity in their workplace." The final rule was made effective on April 18, … [Read more...]
