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).
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.
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).
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.
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.
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.
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?
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.
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.
Have you ever tried reading all of the Food Safety Modernization Act (FSMA) rules, subsequent amendments, exceptions, and Federal Register notices to try to determine which rules apply to your company and what deadline matches your business’ function and company size?