Hello Food Safety Friends,
It’s been a few weeks since I shared my list of what’s posted, and my take. Here’s a compilation.
1. If you’re not knee deep in the structure and function of FDA, you may not realize the significance of yesterday’s announcement from Commissioner Califf, noting the restructure and possible renaming of the Office of Regulatory Affairs (those who do inspections, investigations, recalls and import work). It’s a big deal and, combined with the previously announced changes, signals that the Commissioner has evolved from making incremental change to truly taking advantage of the opportunity to revamp how FDA manages foods. While there have been those who criticize, I'm not going to let perfection be the enemy of good (or at least better). The proof will be in the pudding, and implementation and execution are TBD, but I’m increasingly optimistic.
2. Back in late 2021 I either missed the WHO establishment of a food safety community of practice, or I forgot about it when I re-found it just before World Food Safety Day.
3. The FSIS guidance to retailers on managing Listeria monocytogenes in delis is really good. The content seems solid though not earth shattering. What stood out was the formatting- it is one of the more readable, user friendly government documents. It would be great if other regulatory guidance followed this kind of format.
4. My career has been intertwined with traceability for over 15 yrs (FSMA pilots, book, and more). The journey continues! FDA added resources to their traceability page, including an interesting set of 82 traceability rule FAQs. What stood out to me:
a. FDA finally addresses cross docking (reasonably, I think; as being part of the foods route that is neither the ‘shipping’ nor ‘receiving’ location)
b. Lots of questions on what is and isn’t on the FTL. I expect this will evolve over time and personally I think we know enough about what’s on the FTL start worrying about the big picture vs the corner cases
c. FDA recognizes that foods will be in various stages of distribution and won’t have full traceability records when the compliance date hits. Records need to be kept starting on the compliance date
d. There’s some interesting info on importers, enforcement with respect to foreign firms, and the relationship with FSVP
5. Should we be surprised that a Cyclospora outbreak was associated with imported broccoli? I think no. Although a root cause investigation can’t be done, we can guess that contaminated feces somehow contacted the crop, whether via water (or ice), or some other direct or indirect mechanism. The need to protect produce is not unique to broccoli.
6. FDA released the results of their domestic RTE dips and spreads sampling assignment. Saying that 4/747 samples were positive for a human pathogen doesn’t tell the whole story.
a. It’s clearer to say that Salmonella was found once, in a hummus sample (0.3% of hummus sampled, and 0% of all other sampled products).
b. L. monocytogenes was found in 3 samples, 2 cheese and one cheese/pepper, so about 2.2% for that category, and 0% for others.
c. The other notable thing is that almost ¾ samples were collected at retailers not processors. Why this matters: do processors/manufacturers even know their product was sampled? Do retailers share this information with suppliers, if they even know (or do regulators buy these unnoticed like normal consumers?)? Follow up/ root cause analysis for a positive is also delayed. Hopefully FDA’s facility registration data can help direct regulators to processors in the future.
Please reach out with anything that struck you that I haven’t listed here. As a consultant I’ve still got pretty good information feeds, but I’m sure there are things I’m missing! Jennifer
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