Five of the seven major rules of the Food Safety Modernization Act (FSMA) have been finalized. This means: if you hadn’t already begun to do so, it’s time to look toward compliance, and determine what components of each rule apply to your facility and what you need to do by when.
With a simple web search of “FSMA final rules” bringing up more than 150,000 results, there’s certainly no shortage of information, analyses, and opinion on the new rules—and it’s likely that you’ve read at least a few of them. So what will you find in QA’s features that you haven’t already read somewhere else? And, perhaps even more puzzling, why is QA focusing this issue’s features on the Preventive Controls rules, which were issued two months ago, instead of on the newer final rules for produce safety and imported rules?
Nearly a year ago, when the QA staff was setting its 2016 Editorial Calendar, we purposely, and strategically, set the first of the FSMA Final Rules articles for our December issue—knowing, even then, that the preventive controls rules’ court-mandated deadlines were August 31, and the produce safety and import rules were required to be issued by October 31—well in time for inclusion in this November/December issue.
I have to admit that, with so many missed and extended deadlines on FDA’s issuance of the proposed rules, the decision to wait to focus on preventive controls in this issue and produce safety and imports in the first issue of 2016 was, in part, a “just in case.” Just in case the rules did not, in fact, publish as mandated; just in case the deadlines were extended; just in case the rules hit the Federal Register but weren’t available for review for two or three weeks. (Oh wait, that did happen.)
However, potential delays were not the only consideration. Rather, it was a very strategic decision designed to enable us to bring our readers more in-depth insights on specific areas of the rules, rather than simply reiterating general overviews that have been available since FDA’s first unveiling of the final rules (and little changed since the publishing of the proposed rules). We wanted to work with subject experts to delve into the rules—all 3,257 pages. With each set of rules approximating 1,600 pages (the two preventive controls at 1,590 and produce safety, foreign supplier verification program and accredited third-party rules totaling 1,661), we didn’t feel there would be much value for our readers if we were to ask our subject experts to read, digest, analyze, and provide practical applications for compliance overnight.
Thus, this issue of QA brings you in-depth analysis and application of very specific areas of the final Preventive Controls rules for human foods and for animal foods, including:
In our January/February 2016 issue, we will turn our experts’ eyes to the second set of final rules. As they say: Watch this space!