The U.S. House of Representatives is considering two amendments to the Food Safety Modernization Act (FSMA) that will undermine rules protecting America's food supply. The House has taken up the Farm Bill after it, along with few amendments, was passed by the Senate this week. Update: The House just voted down the Farm Bill on Thursday afternoon. The current Farm Bill will expire in September, and a new one must be in place by then. Amendment 214, sponsored by Rep. Dan Benishek (R-MI) would stop the FDA from enforcing regulations until the government submits scientific and economic analysis of those regulations to Congress. That inhibits enforcement of FSMA regulations and undermines rules already in place. In addition, it would delay FDA's new rules on produce standards, import safety … [Read more...]
FSMA Imported Foods Rule Takes Effect Today
One of the new rules mandated by the Food Safety Modernization Act (FSMA) is being put into effect today. the "Information Required in Prior Notice of Imported Food" is now a final rule and is the law of the land. This rule is designed to stop contaminated food at U.S. borders. If a food that is waiting for clearance into the country has been refused entry by another country, it will be rejected at the border. Food importers must follow this rule, which was originally put into place in 2002 after 9/11. The rule states, "for purposes of this regulation, FDA considers 'refused entry' to mean a refusal of entry or admission of human or animal food based on food safety reasons, such as intentional or unintentional contamination of an article of food. This is consistent with the intent of … [Read more...]
FDA: Third Party Audits To Play A Bigger Role in Food Safety
During a budget hearing before a House subcommittee Friday, FDA Commissioner Dr. Margaret Hamburg said that food inspections were just one of many activities that will comprise the agency’s strategy to protect the nation’s food supply in the next budget cycle. But one element that she described as being “very, very important to our program” will give some in the food safety world pause: third party audits. The U.S. Food and Drug Administration (FDA) uses third party audits of food manufacturing facilities and farms to supplement the inspections it performs. But, as two high-profile food poisoning outbreaks have illustrated, there are serious problems with the way the third-party inspection system works. Chief among them is that growers or companies that make food are often required … [Read more...]
Rep DeLauro to FDA: Tell Us What You Need For Food Safety
The FDA’s hour-and-a-half-long budget hearing before a House subcommittee today began with the chairman enumerating the agency’s many challenges including its glacial pace with respect enacting guidance rules and regulations and filing its budget, and ended with Rep. Rosa DeLauro (D-CT) asking FDA Commissioner Dr. Margaret Hamburg for a breakdown of inspection personnel and an answer to the question: what do you require to ensure the public health of this country? To view C-SPAN’s recording of the hearing click here. Hamburg appeared along with the FDA’s CFO James Tyler and Norris Cochran, deputy assistant secretary of the U.S. Department of Health and Human Services before the House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies to discuss food … [Read more...]
FDA Extends Deadline For Food Safety Rules, Again
Although two proposed rules of the Food Safety Modernization Act (FSMA) are already more than a year overdue, the U.S. Food and Drug Administration (FDA) is extending for the second time the comment period on both of them. The Agency will now be accepting comments on the preventative controls and produce safety rules, formally known as the “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” until September 16, 2013. “These overdue rules, along with the others still delayed, must be finalized and implemented to better ensure the safety of our food. Time and again, I have asked this to be done in a robust, timely fashion. … [Read more...]
Judge Orders FDA to Establish Timetable for FSMA
The Center for Food Safety (CFS) filed a lawsuit against the FDA last fall for failing to implement new food safety regulations as mandated by the Food Safety Modernization Act (FSMA). Yesterday, U.S. District Judge Phyllis J. Hamilton ordered the FDA to work with CFS to establish a new timetable to implement those regulations. CFS senior attorney George Kimbrell said, "today is a good day for food safety and for consumers. Every day without the FSMA regulations is another day where consumers are at unnecessary risk. Because of this decision our food will soon be safer from E. coli and other threats." CFS has compiled a timeline of foodborne illness outbreaks that have occurred since FSMA was enacted on January 4, 2011. FSMA's critical rules, which were signed into law by President … [Read more...]
FDA Extends Comment Period on Produce Safety Rule Again
The FDA has announced it will extend the comment period for the Food Safety Modernization Act's produce safety rule beyond May 16, 2013. The deadline will most likely be extended for another 120 days. The extension is in response to multiple requests from interested parties. This is the second time the comment period has been extended from the original deadline of February 15, 2013. Earlier this month, the FDA also extended the comment period for pilot programs that trace food from farm to table. FDA Commissioner Margaret Hamburg told a U.S. Senate agriculture appropriations subcommittee hearing that "we appreciate that these are complex rules to go through and we do intgent to extend the comment period so we can go through all the concerns and address them fully. I think it's a … [Read more...]
FDA Requests $4.7 Billion Budget
The U.S. Food and Drug Administration (FDA) is requesting a budget of $4.7 billion for fiscal 2014. The proposed budget represents a 21 percent increase over fiscal 2012. The agency says almost all of the budget, 94 percent, will come from user fees including new fees stemming from the Food Safety Modernization Act (FSMA). About $15 million has been trimmed from human drug, biologics, and medical device programs. “These are tight budget times, and the FDA budget request reflects this reality,” said FDA Commissioner Margaret A. Hamburg, M.D., in a statement. “Our budget increases are targeted to strategic areas that will benefit patients and consumers and overall strengthen our economy. Through the good work of the FDA, Americans will receive life-saving medicines approved as fast as or … [Read more...]
FDA Extends Comment Period For Food Safety Act Rule
In response to a number of requests, the U.S. Food and Drug Administration (FDA) has decided to extend the comment period for a notice pertaining to a provision of the Food Safety Modernization Act (FSMA) that requires pilot programs to explore new ways to track and trace food from farm table. Comments for the notice, ‘‘Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food,’’ which appeared in the Federal Register on March 5, are being extended until July 3. The provision to establish pilot projects is required under Section 204 of the FSMA. Under a contract with FDA, the Institute of Food Technologists (IFT) conducted the projects, one for processed … [Read more...]
Questions and Answers on New Food Safety Rules
The Food and Drug Administration (FDA) has released a Q&A on new food safety rules for the Food Safety Modernization Act (FSMA). The questions about the produce rule cover product tracing, record keeping requirements for high risk foods, the scope of the rules, and information about laws, regulations, and guidance documents. And the rules for current good manufacturing practices and Hazard Analysis and Risk-Based Preventive Controls for Human Food cover compliance, fees, inspections, and recalls. Traceability is crucial when there's a foodborne illness outbreak. And since many outbreaks were linked to produce in the last few years, tracing this type of food is important to outbreak control and prevention. Product tracing documents the "production and distribution chain of products … [Read more...]
