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TraceGains Insights Blog Keep up with the latest industry news, tips and more right here!

    American Baker's Association (ABA) Convened in Denver, CO to Discuss Key Issues

    More than 60 members of the American Baker’s Association (ABA) gathered in Denver this week for the summer Federal Technical and Regulatory Affairs Committee (FTRAC) meeting.

    Preventive Controls Qualified Individual: One Size Does Not Fit All Food Manufacturers

    The FDA’s Preventive Controls for Human Food regulation was published on September 17, 2015. It applies to facilities required to register with FDA under section 415 of the Food, Drug, & Cosmetic Act, and these facilities must comply if they manufacture, process, pack, or hold human food. Compliance with this rule became mandatory for large firms in September 2016, and compliance deadlines for “small businesses” (September 18, 2017) is quickly approaching. For this particular FSMA regulation, food companies are required to have a food safety plan in place, and this plan needs to be developed by a Preventive Controls Qualified Individual (PCQI).

    Are Consumers Responsible for Driving FSMA’s FSVP?

    In a roundabout way, yes. In the globalized food industry where complex supply chains are common, the Foreign Supplier Verification Program (FSVP) seems to have been introduced at an appropriate time for Americans.

    The Trump Administration or Whistleblowers: Which Might Have More Impact on FSMA Compliance?

    For small businesses, defined by the FDA as a business that employs fewer than 500 persons, there are fewer than 200 days left to become compliant with FSMA’s Preventive Controls for Human/Animal Food rules (the actual compliance deadline is September 18, 2017).

    FSMA and the New Congress: What’s Likely and Unlikely to Happen

    With this post, we’d like to say that we're not trying to make a political statement for or against anyone. We're simply trying to assess the new dynamics unfolding in Washington and how that might affect the companies we serve. We consistently see a lot of interaction from various government agencies with TraceGains content, and we appreciate the work that you've done and continue to do to implement FSMA. It's important work and we know your jobs aren't easy. With that said, we invited Marc Sanchez, FDA and regulatory attorney, to help us sort out the likely and unlikely.

    Practical Compliance Tips for FSMA from Top Food and Beverage Companies

    While the Food Safety Modernization Act (FSMA) rules have all been finalized for quite a few months now, there are still significant amounts of confusion and questions regarding implementation and what companies actually need to do from a food safety standpoint.

    Take Our FSMA Stress Test to See If You're Ready

    Compliance requirements for the Food Safety Modernization Act are well underway, with large companies already needing to comply with the Preventive Controls for Human and Animal Food rules. Next up is the Sanitary Transportation rule followed closely by the Foreign Supplier Verification Program rule.

    FDA Inspections: Rights and Reasonableness

    When it comes to FDA inspections, it’s rules, and the new rules for the Food Safety Modernization Act's (FSMA) inspections, what are the core rights and responsibilities of your facility?

    Supply Chain Transparency and FSMA

    With the finalization of all rules that make up the Food Safety Modernization Act (FSMA) and compliance dates already in effect for the Preventive Controls rules for large companies, one common denominator stands out amongst them all: the increased need for supply chain transparency.

    Decoding the FDA’s Draft Guidance for HARPC

    The FDA published Draft Guidance on Preventive Controls for Human Food in the Federal Register on August 23, 2016. With over 200 pages thus far, the industry guidance represents the agency's current thinking on the development of food safety plans and hazard analysis as required by the Preventive Controls rule.