Hello food safety professionals,
Here are some of the things I’ve been following the past couple of weeks. What have you seen that’s caught your attention?
1. It’s Cyclospora season. Ugh. I moderated an IFPA virtual town hall on Cyclospora the other week, just before FDA announced that they were investigating an outbreak. I also joined a fascinating FDA Cyclospora Task Force call that dove deeper into the genetics of this parasite(s). (to get a call invite, fill out this form and in the ‘description of inquiry’ say ‘I would like to sign up for the FDA Cyclospora Task Force webinar series. Please send this request to Jasmin Selby’)
2. FDA released a small entity compliance guide to support the final traceability rule. Not surprisingly, given that it’s for small entities, several of the 38 pp explain the exemptions, modified requirements, and opportunities for waivers. Most of the rest is pretty consistent with existing information FDA has shared about rule requirements.
3. The US is not the only country with new traceability requirements. USDA FAS just published a translation of the Egyptian traceability rule which passed in October 2022. Most provisions go into effect in Oct 2023 (some sooner, some later). The requirements are extensive! Farms must share with packinghouses info on water sources and date of last irrigation for each lot; restaurants must keep a record of all ingredients and the approximate weight of each meal served, along with a picture.
4. CDC published a really interesting study of non-O157 STEC cases that were not associated with outbreaks, and compared them to case controls to try to see what factors differed between case controls and patients. I was surprised to see an association between raspberries consumed at restaurants and illness! I was not surprised to see an association with international travel, or exposure to farm animals.
5. In remarks made by FDA CFSAN Center Director Dr. Susan Mayne to the Food and Drug Law Institute, she said that for every 1,000 isolate sequences added to GenomeTrakr, it’s estimated that there is a reduction of 6 illnesses/yr for that pathogen. I wonder how you get at such an estimate.
6. FDA finalized guidance establishing a 10 ppb action level for inorganic arsenic in apple juice.
a. If you’re wondering about the difference between an action level and a tolerance, FDA explains in a footnote “We will establish an action level, as opposed to a tolerance or regulatory limit (which must be established by rulemaking), when technological or other changes that might affect the appropriateness of the tolerance are foreseeable in the near future… we will consider action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case”.
b. FDA sampling data show that this action level is largely achievable, and was even a dozen years ago. So how will this improve public health? I guess that’s why it’s an action level. The document notes “achievability at lower levels has been increasing rapidly in recent years. For instance, achievability at 5 ppb improved from 54 percent for samples collected in FY2011 (based on inorganic arsenic) to 78 percent for samples collected from FY2013 to FY2022 (based on total arsenic).” I expect FDA will decrease the action level at some point. Will it take another decade (this draft guidance was issued in 2013)?
Stay tuned for more depth on these and other topics in the coming weeks.
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