What is an example of a SAHCODHA hazard?
Frantically completing a FSVP here and need to understand SAHCODHA hazards.
We have imported pizza. Would listeria be considered a SAHCODHA hazard for that, even if it requires cooking prior to consumpion? We also have imported ice cream that's ready-to-eat. Would listeria be a SAHCODHA hazard for that?
If a site handles allergens, would allergen cross-contact be considered a SAHCODHA hazard?
Really, a hundred things could be SAHCODHA hazards if NOT controlled.
Hello,
SAHCODHA hazards are those that would prompt a class I recall if they were to occur. Based on that, the answer to all your questions would be "Yes".
So, when considering that a SAHCODHA could be nearly anything if not controlled, do you think my methodology of likelihood and severity, along with a review of emerging issues and recent recalls is valid?
Yes, that is what I am currently doing. I think is also helpful to check what FDA has classified in the past as class I recall. For example: Listeria in hummus has been class I recall. Patulin in apple juice has been classified as class II. Listeria would be a SAHCOHDA hazard, but patulin not.
Hi FC,
In a traditional haccp scheme, the basic haccp requirements would "simply" be to first define the potential BCPA hazards followed, including consideration of prerequisite programs, by a hazard analysis / risk assessment (ie due the process) to determine which of the potential hazards are significant. Followed/associated with CCPs/control measures and all the other familiar steps in the Codex/NACMCF scheme.
FSMA/HARPC has attempted to reorganise the preceding paragraph in various (sometimes mysterious) ways, notably via Preventive Controls. Not my locational area of expertise but, based on the (slightly old) FSVP link below, FDA seem to have a parallel semi-confusion scenario akin to the (still ongoing?) one in HARPC.
http://foodct.com/20...new-fsma-rules/
The inherent difficulty with all probability (eg "reasonably likely"/consequential) based decision rules is that some subjectivity (eg the middle area of risk matrices) is unavoidable due to (a) Interpretation, (b) Definition of Risk Criteria for Action/No actions. This characteristic is fundamental to HACCP Systems.
i am curious as to whether a similar uncertainty element is built into the decision mechanism for Class1, Class 2 etc Recall situations ?. I anticipate that it is. If so, I can understand yr quest for examples. But the usual problem for Authorities is that such examples are only definable at the end of the chain. Hence "Revisions". :smile:
afaik FDA are (supposed to be) in the process of formulating a list of "High Risk" foods which will presumably also be listed with the hazards which render them so. Such a list may assist yr decision queries.
My own area (seafood) went through analogous USFDA haccp convulsions in the 90's. FDA, eventually, and via 3-4 Revisions over 10 years, issued an amazingly ingenious (xy) matrix table which compiled all the (for FDA purposes) potential process hazards along the top(x) against all the typical final product presentations,, eg RTE, NRTE, chilled, frozen, down the left hand side(y). Appropriate pairings of Product/hazard which had to be considered for CCPs were then indicated in the relevant (xy) matrix cells. Basically, to assist the industry, FDA defined for internal/external processors what they had to do to comply with FDA's new Regulations. I imagine the later FDA Juice Regulations did something similar.
Hopefully the HARPC/FSVP will eventually offer a similar, detailed, programmed, assistance but the Product scope/Haccp complexity are in FSMA, presumably, substantially increased, even without the inclusion of FDA seafood/ USDA meat products.
PS - A few additional comments.
I did not see a single example harpc/FSVP plan in my browsing. = Good business for Consultants.
I noticed in my browsing this rather provocative comment in one Company's response to the proposed FSVP rules. May be of interest -
While FDA does provide some examples of SAHCODHA (for example, hazards leading to Class 1 recalls), there is still much in the way of subjectivity. This, then, leads to the question: why would an importer ever lean toward a SAHCODHA determination, especially in a close-call scenario? If the importer doesn’t classify it as SAHCODHA, it won’t have to comply with onsite audit requirements. The importer has a conflict of interest in this situation.
If onsite audits are not required, does the proposed Rule accomplish what FSMA intends to do, which is to ensure that imported foods are held to the same standards as foods produced in the U.S.? Additionally, if FDA can’t even decide whether Option 1 or Option 2 is better, should the decision be left to industry or the entity being regulated ?
I also noticed a few files/link which maybe of some assistance. Not sure if any of these recently posted here already. If so, apologies in advance.
Foreign Supplier Verification Manual,FSVP.pdf 18.76MB 589 downloads
FSVP 1 - Supplier programs for FSVP,2017.pdf 2.65MB 457 downloads
FSVP 2 - fsma-foreign-supplier-verification-program-outline,2016.pdf 524.81KB 435 downloads
FSVP 3 - FSMA - Impact on Dairy,2014.pdf 1.37MB 191 downloads
FSVP 4 - full text,2015.pdf 550.06KB 285 downloads
FSVP 5 - FSVP implementation,2016.ppt 1.21MB 371 downloads
Yes, that is what I am currently doing. I think is also helpful to check what FDA has classified in the past as class I recall. For example: Listeria in hummus has been class I recall. Patulin in apple juice has been classified as class II. Listeria would be a SAHCOHDA hazard, but patulin not.
I don't think the FDA determines Class I and Class II recalls just by the hazard in question. For example, two mixes from a manufacturer were recalled because an ingredient was potentially contaminated with Salmonella. One was considered a Class I recall while the other was a Class II recall. Links to them are below. Now how the FDA differentiates that, I have no idea.
http://www.accessdat...#Product_151762
FDA and USDA are poor at assigning recall classifications consistently across multiple years because of misapplied blanket policies and interpretation by the various districts. Having done a few (recalls) on my end, there's give and take when they're assigned, and sometimes they're applied for the egregiousness of the violation rather than the actual food safety implications (e.g. I once saw a class I recall for a candy company that was underdeclaring sugar on the nutrition facts panel, definitely an immediate risk to public health).
The point is, be careful with using recall classification to assign risk/severity to an issue, because if I dig through the backlog I bet I can find another example that would support a different classification for just about anything.
Mostly just popped on to say that every time Charles posts an answer like this I learn something. It's kind of awesome.