{"id":348,"date":"2015-04-28T16:04:11","date_gmt":"2015-04-28T21:04:11","guid":{"rendered":"https:\/\/www.repete.com\/?p=348"},"modified":"2015-04-28T16:04:11","modified_gmt":"2015-04-28T21:04:11","slug":"fsma-june-2015","status":"publish","type":"post","link":"https:\/\/www.repete.com\/thai\/2015\/04\/28\/fsma-june-2015\/","title":{"rendered":"Big FSMA regulation changes coming in June 2015"},"content":{"rendered":"<p>Many manufacturers don\u2019t fully understand the Food Safety Modernization Act (FSMA), its ramifications, and the steps they should take to protect their businesses.<br \/>\nWith new regulations, including unlikely, but possible, criminal liabilities, becoming effective June 30, gaining some perspective is more important than ever.<br \/>\n<strong>Understanding FSMA and new liabilities<\/strong><br \/>\nEach year, 3,000 Americans die from foodborne illness (Source: <a href=\"http:\/\/www.cdc.gov\/foodborneburden\/estimates-overview.html\">CDC<\/a>). FSMA was enacted to prevent contamination in the food supply chain and save lives.<br \/>\nFSMA has four main objectives:<\/p>\n<ol>\n<li>Improve capacity to prevent food-safety problems<\/li>\n<li>Improve capacity to detect and respond to food-safety problems<\/li>\n<li>Improve the safety of imported food<\/li>\n<li>Miscellaneous provisions, such as whistle-blower protection<\/li>\n<\/ol>\n<p>If your company is required by the FDA to register under its current food facility registration regulations, FSMA applies to you.<br \/>\nIn just two about months \u2013 by June 30, 2015 \u2013 the U.S. Food and Drug Administration must finalize a series of seven regulations that create significant new criminal liabilities affecting companies in the food industry (Source: <a href=\"http:\/\/www.retailleader.com\/article-criminal_liability_exposure_under_the_food_safety_modernization_act__what_every_ceo_should_know-6871.html\">Retail Leader<\/a>).<br \/>\nHow big is this? Once regulations are final, business operations can cease pending investigation and a company CEO can be held personally liable for violating any of the new regulations, even if that CEO had no knowledge of the violation. If your company doesn\u2019t have strong controls in place to manage its production as well as other aspects of the supply chain, you\u2019re taking on significant risk.<br \/>\n<strong>Recognizing the FDA\u2019s reach<\/strong><br \/>\nMore than ever before, FSMA intends to hold the food industry accountable for securing the supply chain. Here\u2019s a short list of what\u2019s within the FDA\u2019s power:<\/p>\n<ul>\n<li>Require a recall rather than recommend a recall.<\/li>\n<li>Require verification of imported ingredients used in U.S.-produced feed; the burden to track is on the manufacturer.<\/li>\n<li>Compel disclosure of records without a warrant.<\/li>\n<li>Detain ingredients or inventory, causing delays in production and even immediate shutdown.<\/li>\n<li>Suspend license of noncompliant operators.<\/li>\n<li>Conduct unscheduled audits, typically records-based. This could force a reconciliation of ingredients, requiring documentation of existing best practices and their application.<\/li>\n<\/ul>\n<p><strong>Protecting your business<\/strong><br \/>\nAutomation is helping the feed and grain industry meet the best practices called for by FSMA and other regulatory requirements. More than lower production costs, automation can improve food safety and help mitigate regulatory and commercial risks.<br \/>\nConsider a common scenario in which a plant operator producing a pre-mix for pet food is preparing hand-adds: An alarm goes off somewhere in the plant, and the operator stops what he\u2019s doing to attend to the problem.<br \/>\nAutomation can ensure that when the operator returns to his station, the plant\u2019s processes aren\u2019t jeopardized. The system can inform where he left off in the process, preventing errors such as too many, or not enough, ingredients from being added.<br \/>\nAdditionally, data from the plant\u2019s control system, including lot tracking, can automatically verify regulatory compliance and prove the product was manufactured correctly. The audit trail provides assurance of quality and consistency to the plant\u2019s customer, and the FDA.<br \/>\nYet, automation alone is not enough to protect you. A software platform verging on obsolescence increases risk. Manufacturers who operate on systems that are difficult to support or prone to error should not ignore what could be a ticking time bomb.<br \/>\nIs automation imperative for meeting FSMA requirements? No. Manual processes can keep you compliant, although they naturally invite human error. Cost is also a consideration. Manual processes can add production time and steal from your bottom line.<br \/>\nTremendous advancements in process automation technology give you more options for protecting your business, people and their animals. Those who can provide assurances of safety and compliance will gain their customers\u2019 trust \u2013 and a competitive advantage.<br \/>\nNeed some help understanding FSMA and how to be prepared? <a href=\"https:\/\/www.repete.com\/lets-talk\/\">Let&#8217;s Talk.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Many manufacturers don\u2019t fully understand the Food Safety Modernization Act (FSMA), its ramifications, and the steps they should take to protect their businesses. With new regulations, including unlikely, but possible, criminal liabilities, becoming effective June 30, gaining some perspective is more important than ever. Understanding FSMA and new liabilities Each year, 3,000 Americans die from foodborne illness (Source: CDC). FSMA was enacted to prevent contamination in the food supply chain and save lives. FSMA has four main objectives: Improve capacity to prevent food-safety problems Improve capacity to detect and respond to food-safety problems Improve the safety of imported food Miscellaneous provisions, such as whistle-blower protection If your company is required by the FDA to register under its current food facility registration regulations, FSMA applies to you. In just two about months \u2013 by June 30, 2015 \u2013 the U.S. Food and Drug Administration must finalize a series of seven regulations<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":17,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[9],"tags":[],"class_list":["post-348","post","type-post","status-publish","format-standard","hentry","category-resources"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Big FSMA regulation changes coming in June 2015 - Repete Thai<\/title>\n<meta name=\"description\" content=\"FSMA regulation changes in June 2015 that create significant new criminal liabilities affecting companies in the food industry.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.repete.com\/thai\/2015\/04\/28\/fsma-june-2015\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Big FSMA regulation changes coming in June 2015 - 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