December 7, 2016

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 facilitiesĀ are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination. They 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 training and maintain records. Before 1982, most food and drug products did not have tamper-proof packaging or tamper-resistant seals. In 1982, seven … [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...]

FSMA Final Rule on Sanitary Transportation of Food Released

The FDA has released the final Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food. The earliest compliance dates for some firms begin one year after publication of the rule in the Federal Register. Problems in transportation, including mishandling and dirty containers, have been the cause of some food poisoning outbreaks over the years. The goal of this rule is to "prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food." The rule builds on safeguards envisioned in the 2005 Sanitary Food Transportation Act. Unsanitary transportation practices have been discovered over the years, and regulations are … [Read more...]

FDA Addresses Spice Safety

The FDA has been analyzing a two year nationwide study to collect information on the presence of Salmonella in retail packages of spices consumers buy in supermarkets, ethnic markets, discount stores, and on the internet. There have been several recalls of spices and herbs in the past few years for Salmonella contamination, and a Salmonella outbreak linked to spices in Sweden sickened 178 people last summer. An FDA report in 2013 found that 12% of imported spices are tainted with pathogenic bacteria or filth. The draft risk profile found that the presence of pathogens such as Salmonella, and filth in spices is a "systemic challenge" and that the problem relates in part of poor or inconsistent use of appropriate controls to prevent contamination. In the study, spice shipments from 79 … [Read more...]

CFA Disappointed with Food Safety Funding Budget Request

The Consumer Federation of America (CFA) is disappointed with the President's FY 17 budget request for food safety funding for the Food and Drug Administration, which proposes almost no new funding for food safety activities. Thomas Gremillion, Director of Food Policy at CFA said in a statement, "with the Food Safety Modernization Act, Congress recognized the need for FDA to implement a new system - one that prevents foodborne illness rather than reacting to it after the fact. FDA needs adequate funding to take on its new oversight responsibilities under FSMA. The President's budget will mean more delay in implementing the law, which Americans will pay for in the form of avoidable hospitalizations and deaths caused by foodborne illness." FSMA passed through Congress in 2010. The FDA … [Read more...]

FDA Examining Raw Milk Cheese Criteria

Cheesemakers, especially artisan producers, have suggested that the FDA is applying safety criteria to raw milk cheese production that limits producers without benefitting public health. Raw milk cheeses have been linked to recalls and food poisoning outbreaks in the past several years. Raw milk cheese produced by Family Cow in Pennsylvania caused Campylobacter illnesses in 2013, and there have been dozens of recallsĀ of raw milk cheeses over the years. Raw milk cheese has been recalled for Campylobacter, Salmonella, E. coli, and Listeria monocytogenes contamination in all of the four years Food Poisoning Bulletin has been published. Some studies have concluded that aged raw milk cheeses are safe to eat, since the aging process changes the composition of the cheese. Aging reduces the … [Read more...]

FDA Finalizes FSMA Rule for Food Importers

The FDA has finalized the Foreign Supplier Verification Programs for food importers, in accordance with the Food Safety Modernization Act of 2011. This rule requires that food importers perform "certain risk-based activities to verify that food imported into the United States has been produce din a manner that meets applicable U.S. safety standards." FDA head Michael Taylor said in a statement, "under the new rules, importers will have the obligation to verify they are meeting U.S. standards. This is a fundamental paradigm shift from the FDA detecting and responding to problems with imported foods to industry being responsible for preventing them." Imported food makes up almost 20% of the food Americans eat. We import 52% of fresh fruits and 22% of the fresh vegetables in our diet. … [Read more...]

FDA Finalizes FSMA Rules on Produce Safety

The FDA finally finalized the rules on produce safety last week. Michael Taylor, the head of that agency said in a statement, "Its been a long and arduous task, to say the least. Finalizing the rules is just one part of building a modernized food safety system." The Food Safety Modernization Act was passed in 2011. The major rules in that Act have been slowly finalized by the FDA and the Office of Management and Budget. This latest new rule targets produce grows. They must ensure the safety of water in irrigation, since some outbreaks have been caused by produce contaminated by irrigation water that contains Salmonella or E. coli bacteria. They must make sure workers practice good hygiene in the field and while packing. A Cyclospora outbreak linked to imported cilantro lead to a ban … [Read more...]

Senator Durbin Vows to Continue Fight for FSMA Funding

Senator Dick Durbin (D-IL) has called for providing the FDA with the funds it needs to fully implement the Food Safety Modernization Act of 2011 (FSMA). The Senate appropriations committee passed a bill that fell short of the monies needed. The vote was along party lines. Durbin said that the huge recall of Aspen Foods and Barber Foods that are linked to two Salmonella outbreaks in Minnesota, Wisconsin, and Oklahoma highlights the need for increased vigilance. "The food safety allocation in this bill falls short of what is needed to reduce foodborne illness in this country," he said in a statement. The Food and Drug Administration estimates that it will take $276 million in additional funding to properly implement FSMA. The President's budget requested an increase of 109.5 million … [Read more...]

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