The U.S. Food and Drug Administration (FDA) has announced it will not enforce certain provisions of the Food Safety Modernization Act (FSMA) because the agency needs more time to consider "the complex supply chain relationships and resource requirements” related to definitions and required disclosures. Among other issues, FDA stated, are questions about factors such as farm ownership and farm-related activities that affect the determination of what business entities are “farms.” In addition, FDA will delay enforcement of some provisions related to (i) produce safety; (ii) disclosures regarding hazard analyses; (iii) importation of food contact substances under the Foreign Supplier Verification Program; and (iv) human food byproducts used in animal food.
Tag Archives food safety/FSMA
A report from the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services has concluded that the Food and Drug Administration (FDA) fails to adequately conduct or follow up on food-safety inspections required by the 2011 Food Safety Modernization Act (FSMA). OIG reportedly found that while FDA is “on track” to meet inspection timeframes for the initial mandate, future inspection timeframes are two years shorter and FDA may not be able to meet them. The report also stated that FDA did not always take action when it found significant safety violations and that the agency “commonly relied on facilities to voluntarily correct the violations” instead of taking advantage of FSMA administrative tools. FDA “consistently failed to conduct timely followup inspections” to ensure facilities made the necessary corrections, the report noted. In addition, “inaccuracies” in domestic facility data caused FDA to attempt inspections at the…
The U.S. Food and Drug Administration (FDA) has announced that the produce safety rule of the Food Safety and Modernization Act of 2010 (FSMA) is now final, establishing minimum standards for the growing, harvesting, packing and holding of raw produce for human consumption. Compliance dates are staggered but will affect large operations first. The key requirements include: (i) establishment of criteria for microbial water quality based on the presence of E. coli; (ii) rules governing the use of raw manure and compost; (iii) testing and corrective-action requirements for cultivation of sprouts; (iv) rules for assessment of contamination by domestic livestock and wild animals; (v) measures for worker training, health and hygiene; and (vi) standards for equipment, tools and buildings. Qualified exemptions and variances are also included for small farms, tribes and foreign countries that export food to the United States.
Former U.S. Food and Drug Administration (FDA) Commissioner for Foods David Acheson has authored an article warning food company officials to prioritize food safety in light of the U.S. Department of Justice’s (DOJ’s) increasing prosecutions against executives of food companies responsible for pathogen outbreaks. Acheson describes the Park Doctrine, which allows the government to seek misdemeanor convictions against company officials without requiring proof that the officials knew of or participated in the federal Food, Drug and Cosmetic Act violations. Further, after a misdemeanor conviction, subsequent violations are automatic felonies. “It is for all these reasons that it is critical that everyone in a food facility understand and follow all food safety practices, and that executives stay tuned in to everything going on in their operations—as they are ultimately responsible for every act that takes place,” Acheson writes. “Additionally, while I caution against simply writing up a food safety plan in order…
The Center for Science in the Public Interest (CSPI) has filed a lawsuit seeking to compel the U.S. Food and Drug Administration (FDA) to act on the organization’s 2012 citizen petition seeking establishment of a performance standard for controlling Vibrio vulnificus, bacteria responsible for several deaths related to seafood consumption. Ctr. for Sci. in Pub. Interest v. FDA, No. 16-0995 (D.D.C., filed May 25, 2016). CSPI argues that FDA has violated the Administrative Procedure Act by delaying its response to CSPI’s citizen petition urging the agency “to establish a performance standard of nondetectable for V. vulnificus in raw molluscan shellfish” under the Food Safety Modernization Act. “Every year, people are getting sick and some are dying from what is a completely preventable disease,” CSPI Senior Food Safety Attorney David Plunkett said in a May 26, 2016, press release. “For too long the FDA has observed these illnesses and deaths from…
The U.S. Food and Drug Administration (FDA) has issued a finalized rule under the Food Safety Modernization Act (FSMA) that is intended to help prevent the contamination of human and animal food during transportation. Among other things, the sanitary transportation rule requires those transporting food by motor or rail vehicle to follow recognized best practices for hygiene, including the provision of appropriate temperature control, cleaning between loads and security measures. The rule was initially proposed in February 2014 and its final iteration took into consideration the comments of some 200 stakeholders. See Federal Register, April 6, 2016. Issue 599
London-based Trans Atlantic Consumer Dialogue (TACD), a collaborative group of U.S. and E.U. consumer organizations that develops and submits joint consumer policy recommendations to the U.S. government and European Union, is hosting a January 26, 2016, meeting in Brussels, Belgium, focusing on use of the precautionary principle in the Transatlantic Trade and Investment Partnership. Discussions at the event will include an overview of the precautionary principle in trade agreements and how it is used in the United States and European Union; and precautionary approaches to food safety (e.g., BSE, GMO, hormones, GRAS), pesticide/biocide regulation, digital and privacy rights, and intellectual property. Speakers will include U.S. Federal Trade Commissioner Julie Brill and E.U. Trade Commissioner Cecilia Malmström. Issue 585
The U.S. Food and Drug Administration (FDA) has filed three final rules under the Food Safety Modernization Act (FSMA) on produce safety, foreign supplier verification programs (FSVPs) and accredited third-party certification, all slated for publication in the November 27, 2015, edition of the Federal Register. The agency will also hold a webinar series to discuss the new rules, which are intended to “establish enforceable safety standards for the production and harvesting of produce on farms and make importers accountable for the safety of the food they bring into the U.S.” The produce safety rule addresses, among other things, (i) the quality and testing of agricultural water, (ii) biological soil amendments such as raw manure and stabilized compost, (iii) food safety requirements for sprouts, (iv) the management of domesticated and wild animals, (v) health, hygiene and worker training, and (vi) sanitation standards for equipment, tools and buildings. FDA also describes hazard…
The U.K. Food Standards Agency (FSA) has issued a call for research exploring how the Internet of Things (IoT) could affect food safety. Working with The IT as a Utility Network Plus, FSA seeks short-term pilot studies “intended to test new ideas or create novel linkages between research areas.” In particular, the joint initiative seeks to focus on (i) “IoT data, data standards and sharing”; (ii) “IoT transport and food, particularly temperature control”; (iii) “organizing hackathon events to exploit, disseminate and excite opportunities of IoT from farm to table”; and (iv) “what happens to food in people’s homes.” FSA will accept submissions until November 2, 2015. Issue 581
“American consumers expect and deserve safe food. Yet, time and again, food producers have cut corners on food safety knowing full well that tainted products cause serious illness or even death,” asserted American Association for Justice (AAJ) President Larry Tawwater in issuing a report condemning industry for allegedly prioritizing profits over people. The report contends that consumer lawsuits have become the most effective “mechanism for deterring negligent behavior and rooting out systemic problems in the food chain” absent adequate food-safety practices by food companies and appropriate monitoring by regulators. Among other things, AAJ calls on Congress to declare multidrug-resistant Salmonella an official adulterant and to enact legislation creating a single food safety agency. AAJ was formerly known as the Association of Trial Lawyers of America (ATLA). See AAJ News Release, September 2, 2015. Issue 577
