FSMA and Trump
This just in
http://www.foodsafet...-on-back-burner
This week, President Donald Trump released an outline of his first federal budget. His 2018 budget plans include slashing the U.S. Department of Agriculture’s (USDA) funding by a whopping $4.7 billion.
OMG. It never occurred to me that FSMA could be under threat. It was shocking to be recently audited by an FDA auditor to be told how little power they had until recently that they could only request foods were taken off the market, no power to impound foods, no power to stop somewhere manufacturing. It was terrifying. Seeing the number of outbreaks in the US which have caused deaths it is the one area surely anyone thinks needs more regulation and oversight? Whether the FSMA is the right tool? I'm not sure, it perhaps is overly complex but I wouldn't throw it out now. I wonder if that's his plan?
At this point, nothing that the president does or thinks would surprise me!
It's important to remember that a proposed budget put forth by a US president is not a decree - the "power of the purse" is in the hands of the US congress. That said, a "USDA funding cut" does not necessarily mean that its inspection branch, the FSIS is being cut. The USDA encompasses an incredible array of programs most of which have little or no relation to food safety.
I have a different view of the claim I hear from FDA folks from time to time that they did not have the power or had little power to detain foods. They did have the power before FSMA if they had "credible evidence or information" that the food was likely to be injurious to health. I'll leave aside the how the size of the company tends to correlate with detention of product. The criteria for detention expanded under FSMA.
One should also keep in mind that new legislation (such as FSMA) in reaction to an undesirable situation often sweeps up with it people or entities that did not have the problems being addressed in the first place. But we must comply nonetheless and bear the costs caused by industries (such as Dole lettuce) who could not or would not produce safe food.
Here, the federal inspectors have as much or more power than the RCMP including search and seizure without a warrant
Yep in the UK the powers are pretty tough. Can inspect premises without notice, can impound stock, stop production without going to a judge. With good reason too, a mistake from an Environmental Health Officer in the UK may cost a day's trading. A mistake in not closing a premises could cost a life.
"One should also keep in mind that new legislation (such as FSMA) in reaction to an undesirable situation often sweeps up with it people or entities that did not have the problems being addressed in the first place. But we must comply nonetheless and bear the costs caused by industries (such as Dole lettuce) who could not or would not produce safe food."
Yes, I see your point but there but for the grace of God go I... Just because you've not had an issue yet, doesn't mean you never will. I once went into a company who'd never had a problem then they had one which almost destroyed it and not for want of trying not to have the issue. While I agree onerous legislation can be problematic, the drive to improve standards in the UK is ironically not mainly through legislation but through retailer standards and pressure and that is far more onerous than the legislation in the UK, mostly driven by the EU which is still pretty tough compared with some other countries.
"Just because you've not had an issue yet, doesn't mean you never will."
That is very true. That said, FSMA does not address our specific risks. Ironically, the time and energy spent on some of the new requirements distracts from actual food safety improvement projects that I could be doing. Again, this is our specific situation.
It's not just me. 5 of the 7 auditors (4 of them PCQI trainers) I've had since the final rule was out shares this opinion, the other two did not comment. So therefore, I must be right! :whistle:
The headline of the story linked in the OP is sensationalized, unfortunately. Nothing to panic about...yet...
OMG. It never occurred to me that FSMA could be under threat. It was shocking to be recently audited by an FDA auditor to be told how little power they had until recently that they could only request foods were taken off the market, no power to impound foods, no power to stop somewhere manufacturing. It was terrifying. Seeing the number of outbreaks in the US which have caused deaths it is the one area surely anyone thinks needs more regulation and oversight? Whether the FSMA is the right tool? I'm not sure, it perhaps is overly complex but I wouldn't throw it out now. I wonder if that's his plan?
Hi GMO,
I suggest the auditor was slightly having you on. Perhaps no "direct" power.
As for FSMA, I am still waiting to understand the reason for it's introduction ?
Google has "It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it." I thought this was answered by HACCP.
Don't kid yourself Charles..........the way food is processed and inspected in the US is not handled by HACCP, there is far too much state handled vs federally handled inspection.......some meats do not have to be federally inspected to cross state lines etc etc etc. If the law isn't there to back up what we all know is right, it simply will not get done
I also know that Canada and the US agreed to align each countries programs to promote import/export between us (one another largest trading partner) as our systems were so different, they needed for both countries (Canada is also in the beginning of a huge change *safe food for Canadians regulations) to make both sides of the border automatically (federally inspected only) pass the foreign supplier verification process (meaning Canada has agreed in writing that we will not question your process and the USA has done the same)
As an example, all federally inspected meat processors in Canada have inspectors on site during production, this "daily presence" is a term of trade and a commitment Canada has made. So even if the new Canadian regs allowed say packaging of whole muscle meats post inspection, without an inspector in the establishment, Canada would be violating the terms of trade.
In a nutshell, make our food safety systems nearly identical and cut out cross border red tape.
"the way food is processed and inspected in the US is not handled by HACCP"
Well I've been in the food industry in the US since 2004 in USDA, FDA, and even animal feed. We all operated with HACCP. My local meat locker operates with HACCP.
That said, not impressed with many of the inspectors state or federal.
Yes, but I still don't know what is the justification for FSMA ? I guess from the name it must have something to do with Safety.
And presumably something, safety-related, which (some) current haccp's have failed to provide.
(For some reason, I understand that all USDA operations/Juice-Seafood FDA are exempted, presumably because their haccp's are considered superior/satisfactory in some way to the "others").
It's a mystery to me. :smile:
addendum
Totally OT but I am still waiting to see the long ago (2years?) promised FDA list of High Risk finished products.
AFAIk, not even drafted yet ? Part of the 4.7 Bln$ ?
Yes, but I still don't know what is the justification for FSMA ? I guess from the name it must have something to do with Safety.
And presumably something, safety-related, which (some) current haccp's have failed to provide.
(For some reason, I understand that all USDA operations/Juice-Seafood FDA are exempted, presumably because their haccp's are considered superior/satisfactory in some way to the "others").
It's a mystery to me. :smile:
The more I've learned about their approach to HARPC, the more it (in a way) makes sense. The reason being it focusses more on prerequisites. A good HACCP plan will also have some robust prerequisite controls too but I'm guessing they've had a lot of bad HACCP plans, hence the change. I wouldn't say that outside the US we're much better though; if you look at the likely root causes for food safety recalls, >90% are prerequisite not CCP related. Does that mean you scrap HACCP? No, you work with an essentially good system to make it better.
It is an irony that the one country in the world which has a strange attitude to HACCP, almost distancing themselves from it is the country that invented the concept.
Afraid I started to give up on HARPC at the first fence when I initially saw the fundamental requirement that a hazard analysis (ie a risk assessment) must assume that all existing controls are (somehow) inactive. I couldn’t find a single publication which satisfactorily explained the logic behind this and it just seemed silly to me.
PRPs were traditionally supposed to be system-wide, environmental hygiene controls. Even the 1997 NACMCF dodged a bit around this concept but ISO really finished it off IMO. Now it’s a free-for-all. PRP = hygiene + "QA".
But if that’s what people want……
Then we come to haccp Validation. :whistle:
Afraid I started to give up on HARPC at the first fence when I initially saw the fundamental requirement that a hazard analysis (ie a risk assessment) must assume that all existing controls are (somehow) inactive. I couldn’t find a single publication which satisfactorily explained the logic behind this and it just seemed silly to me.
PRPs were traditionally supposed to be system-wide, environmental hygiene controls. Even the 1997 NACMCF dodged a bit around this concept but ISO really finished it off IMO. Now it’s a free-for-all. PRP = hygiene + "QA".
But if that’s what people want……
Then we come to haccp Validation. :whistle:
Just finished my PSCI training last week, and it was basically two days of HACCP.
What I get from it is that FDA wanted a real risk assessment, not the ones typically thrown together by producers (I have programs for this, so it'll never happen!), and they wanted to see sanitation addressed in the HACCP plan rather than as a prerequisite program, because IMEX the majority of problems with food safety on the floor (originating in the plant) were sanitation based, especially in products lacking a kill step.
Oh, and they wanted to explicitly require manufacturers to audit vendors annually so that FDA doesn't need to take responsibility for it. FDA does not consider an FDA audit to be sufficient to ensure safety.
We have a full time USDA inspector on site, yes every day, all day. The amount of waste in the USDA is astronomical. For many plants that they staff full time, it is no longer about food safety, but jobs all the way up the branch. Our 3rd party audits are much more stringent than anything USDA does. They send in inspectors all of the time to babysit, who aren't even trained in the basic operations of a pasteurizer. WE always end up training the USDA inspectors.
Hate to say it, but trimming the fat in that department sounds about right to me. Food safety won't be compromised in USDA plants in my opinion.
Just finished my PSCI training last week, and it was basically two days of HACCP.
What I get from it is that FDA wanted a real risk assessment, not the ones typically thrown together by producers (I have programs for this, so it'll never happen!), and they wanted to see sanitation addressed in the HACCP plan rather than as a prerequisite program, because IMEX the majority of problems with food safety on the floor (originating in the plant) were sanitation based, especially in products lacking a kill step.
Oh, and they wanted to explicitly require manufacturers to audit vendors annually so that FDA doesn't need to take responsibility for it. FDA does not consider an FDA audit to be sufficient to ensure safety.
Hi 3F,
If you are right, it seems the FDA have a different viewpoint towards Prerequisites than Codex.
Afaik Codex have always regarded the satisfactory implementation of PRPs (mainly focused on hygiene) to be mandatory prior to attempting a hazard analysis, ie as a literal “Prerequisite” to the HACCP Plan. Unfortunately this concept was rapidly subverted via, for example, (a) the early introduction of Sanitation CCPs (all over the place) and (b) expansion of the scope of PRPs into the Process itself (thanks ISO).
Ironically, after 2+ decades, FDA now seem to be going full circle back to (a), albeit with a new Title. Desperation ?
It was weird, and a newly hired FDA inspector was attending the training as well to learn how to enforce it. So it was good to know that the training I received matched what they're auditing against.
I still find it frustrating that they (FDA) kept maintaining it wasn't HACCP, but then make anyone under seafood HACCP, juice HACCP, and LACF regulations exempt. That tells me that they were unsatisfied with the HACCP plans they saw, but considered the ones prescribed by the government to be acceptable.
During the training we spent about half the time discussing about how we could use our existing HACCP plans (those of us under 3rd party schemes etc. who had them already) just by changing the terminology. You just need to identify preventative controls that fall under the PC umbrella (supplier approval, allergen labeling, and sanitation), were not a "process control" (which you can still call a CCP), and not one of FDA's identified pre-requisite programs (cGMP's like pest control).
Basically, if something on the risk matrix for your hazard analysis fell below the CCP-line, but above the "it's never happened" line, and it happened to be controlled by sanitation, allergens labeling, or suppliers, you created preventative controls. If it was controlled by a practice identified in the cGMP's, then it's still considered controlled by pre-requisite programs like maintenance and pest control.
It's a maze but I think I finally get it. The frustrating part is that I feel like I'm writing a program to satisfy an auditor rather than doing an honest hazard analysis and treating my programs as pre-requisites to producing food.
Hi 3F,
Interesting stuff. Thanks. I thought the last paragraph was the saddest and the second one the most "potent".
From distant memory, i believe one of the major reasons for the launching of FSMA was the continual (ie every year) rejection of many lots simply due to deficient allergen labelling. This was, together with some other reasons I can't remember, somehow interpreted as demonstrating that the current US/HACCP system (bar the previously noted and USDA?) was inadequate and a total re-think was neccesary.
I do wonder how HARPC is intended to solve the problem noted above ?. Hmmmm.
addendum
Seems that my recollections were faulty, or perhaps not the Official driving forces for FSMA.
Here are 4 references detailing the motivations behind FSMA.
They are vaguely split 2/2 regarding agreement as to the justification of FSMA/it's likelihood of success.
http://www.foodsafet...e-a-difference/
http://www.foodsafet...-modernization/
Review of Justifications for FSMA(1),2013.pdf 393.1KB 11 downloads
Review of Justifications for FSMA(2),2015.pdf 354.16KB 14 downloads
A little topic drift coming. Exhibit A: Blue Bell ice cream and Aspen Hills cookie dough. What is substantially different now than before FSMA?
A little topic drift coming. Exhibit A: Blue Bell ice cream and Aspen Hills cookie dough. What is substantially different now than before FSMA?
Required environmental and product monitoring for Listeria with associated preventative actions. Supplier approval and verification programs for known hazards.
Of course, much of that would be covered by GFCI scheme, and BB never revealed whether they were subject to one, which was surprising given their size.
Hi 3F,
If you are right, it seems the FDA have a different viewpoint towards Prerequisites than Codex.
Afaik Codex have always regarded the satisfactory implementation of PRPs (mainly focused on hygiene) to be mandatory prior to attempting a hazard analysis, ie as a literal “Prerequisite” to the HACCP Plan.
Yes I agree but I don't think the two concepts have to be in conflict. How I've tried to approach our HACCP plan for compliance to at least part of HARPC is to be really clear about what prerequisite controls the hazard. I know this has been best practice for years but I mean being really specific right down to SOP numbers. I then take those prerequisites and work out what we have in place to monitor or verify them (not all prerequisites can be monitored) and what we have in place to validate them. It's raised a good few questions that an established HACCP plan has missed. I'm yet to do my PCQI course though so I may have misunderstood and it could all change... What's key for us though is HACCP is UK law so I can't dump it completely, I have to find a middle way which complies with it all but then considering I supply most major world retailers, I'm kind of used to it... :smarty:
Hi GMO,
I did watch/study the initial example harpc offerings here but when I saw all the BS presentations appearing on the IT I lost interest for the time being.
Afai can see, despite the official(?) training courses, the basic requirements for doing hazard analyses in harpc remain unresolved. Stage 6/12. I guess the can will stop being kicked if any Companies find their harpc plans being found incomplete.
I haven't noticed any reports of harpc plans being officially scrutinised yet ?
Required environmental and product monitoring for Listeria with associated preventative actions. Supplier approval and verification programs for known hazards.
Of course, much of that would be covered by GFCI scheme, and BB never revealed whether they were subject to one, which was surprising given their size.
True, though the end result is the same. We have a recall and a bunch of reacting.