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Even though many of the sections that make up the new combined FSMA regulations are published and in a complete form, this year we will see two new sections being released as a final ruling.
By Peter Norton
Author: Peter Norton
Peter Norton is a senior logistics and supply chain manager and consultant to the life science industry, with extensive experience in both the domestic US and global markets.
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According to FDA Commissioner Margaret Hamburg, “Nearly 40 percent of the drugs Americans take are imported, and nearly 80 percent of the active ingredients in the drugs in the American market come from overseas sources.” The World Health Organization estimates that "Of the approximately 4 billion prescriptions written in the U.S. in 2011, 40 million were likely fraudulent."
The produce industry is getting prepped for the release of the final phase of the Food and Drug Administration’s Preventive Controls for Human Food ruling. Going forward, you’ll be seeing an increase of innovative applications being used throughout the food distribution chain; all aimed at reducing the loss of product during storage or in-transit.
By Ray Caron
Author: Ray Caron
Ray joined DeltaTrak in 2010 as Marketing Manager and currently holds the position of Senior Vice President of Marketing, Business Development and Chief Operating Officer of DataMark Inc.
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In an effort to improve food safety and omit overlap between authorizing agencies, The Safe Food Act of 2015 was introduced in both houses of Congress on January 28th. This bill was introduced by Sen. Dick Durbin (D-IL) and Rep. Rosa DeLauro (D-CT).
The 7 Pillar Rules are advancing into the final stretch. The FDA will have their action plan ready to implement in 2015-2016. Essentially, the gavel will hit the sounding block before the next Presidential election, or at the time the court-imposed deadlines approach.
Let’s say you’re ‘small potatoes’ in a field of industry giants. If your company is a registered facility under the U.S. Food Safety Modernization Act, you’re probably worried about compliance costs and uncertainties once the FSMA rules comes into play. If you are not particularly thrilled about this new regulation, and feel these rules will yield headaches instead of benefits – look for the silver lining.
Food defense is a top priority within your company, right? If you’re raising one eyebrow and asking yourself, “Just what does it mean to be ready for an audit?” then look into the mind of an auditor to find out exactly what it takes to pass an inspection – and pass with flying colors!
Do you have an up-to-date food safety plan? How secure are your sanitary transportation operations? Are your standards and procedures on par with the sanitary cold chain market? Do you have an HACCP plan in place already? If you were approached for an audit, would you pass an FDA inspection and be able to show officials your records dating back at least two years?
If all goes as the FDA plans with its Food Safety Modernization Act, importers will soon be required to meet the same level of public health protection as food that is produced in the United States. The new law is meant to significantly enhance the FDA’s ability to oversee the millions of food products coming into the United States from other countries each year. This ruling is also intended to reduce annual costs associated with imported foods and food borne illness.
With all the “Breaking News” headlines we receive related to food safety matters, it is easy to get troubled on the domestic front, or for any of us that travel abroad. The weekly saturation of emails and notices I read on this topic reveal disturbing facts that would turn even the most iron-clad of stomachs sour.
Ongoing programs like the VFC (Vaccines for Children) and the Pneumonia vaccine for the older members of the community are seen as annual programs. However, we always associate the Flu vaccine with fall and winter.
Is your company meeting Produce Traceability Initiative (PTI) guidelines? This initiative was introduced in 2009, and has been built as a roadmap to a common standard for external traceability. Implementing this initiative is a critical strategy that will help your company comply with strict food safety and supply chain regulations.
According to the FDA, an estimated 83,609 businesses will be affected by FSMA and the proposed Sanitation Transportation Rule. These businesses must start complying with the new requirements 60 days after the final ruling. The FDA has recently extended the comment period on this proposed rule to July 30 2014, with some leeway being given to smaller businesses.
With the recently proposed FSMA ruling set forth by the FDA, Deltatrak, Inc. is poised to establish itself within the food industry as a leading cold chain monitoring and solutions-based company. DeltaTrak’s contamination prevention tools and monitoring technology will help handlers, suppliers, and distributors comply with the Sanitary Transportation of Human and Animal Food Rule's strict guidelines and food safety standards.
Most of the focus of this blog is generally on the pharmaceutical side of the business related to cold chain, supply chain and the management of temperature controlled drug related products.