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#1 franklin12

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Posted 25 May 2017 - 02:20 PM

How can I be in compliance with a foreign animal food manufacturer (>500 full time employees) for the FSVP on May 30, 2017 if they do not need to be in compliance with the Preventive Controls for Animal Food until September 17, 2017? Now I understand that the manufacturer would need to be in compliance with the CGMP portion since September 17, 2016, but that doesn't help with verifying preventive controls that the manufacturer doesn't have documentation for. Per below:

 

FSVP importer of animal food whose foreign supplier is subject to the current good manufacturing practices (“CGMP”) requirements in subpart B of 21 CFR part 507 in the PC rule for animal food. Compliance dates when foreign suppliers are in these categories:

“All Other” Businesses: May 30, 2017

 

There is a deadline of March 19, 2018, but that is only applicable when the facility does not to be in compliance with the CGMP portion. This I think only applies to facilities that process both human and animal food as being in compliance with the CGMPs for human food can cover the CGMPs for animal food. Per below:

 

FSVP importer whose foreign supplier is required to comply with the animal food preventive controls requirements in subpart C of part 507 of the PC rule for animal food, but that is not required to comply with the CGMP requirements in subpart B of 21 CFR part 507. Compliance dates when foreign suppliers are in these categories:

  • “All Other” Businesses: March 19, 2018

 

Would this mean just getting a statement that the supplier has CGMPs in place, but I would not be conducting a hazard analysis/verification activities? Any clarification would be much appreciated.

 

Links:

Animal Food: https://www.fda.gov/...ompliance_Dates

FSVP Compliance Dates: https://www.fda.gov/...A/ucm503822.htm

 

 


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#2 Simon

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Posted 22 June 2017 - 07:17 PM

Hi Franklin, to me it sounds a very complex question and as no replies (which is unusual), maybe other members are in the same boat.  Have you already managed to find your answer elsewhere?  Failing that is it possible to contact FDA for advice?

 

Regards,

Simon


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#3 franklin12

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Posted 23 June 2017 - 01:22 PM

Sadly I have not. I've reached out to the FDA over this but haven't received a reply from them either.

 

I don't think it is too complex of a question, but the lack of clarity in the guidance is what is stumping me. Essentially to be in compliance with the FSVP, a hazard analysis, supplier approval/evaluation, and supplier verification of controls must be conducted. Since animal food manufacturers do not need to be in compliance with preventive controls just yet, conducting supplier verification of controls that are not in place yet is not possible. Due to the deadline, my uncertainty lies in what is actually needed to be in compliance. 


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#4 Charles.C

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Posted 23 June 2017 - 07:36 PM

Hi Franklin,

 

Apologies my total ignorance of animal food market but is yr query equivalent to the questions already raised/discussed here over SARCODHA (or SACODHA?) which also seems to have some rather potentially odd consequences ?


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Charles.C


#5 franklin12

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Posted 03 July 2017 - 10:13 PM

Hey Charles,

 

So my question is more directed toward the mismatching compliance dates set by the FDA and what is required.

 

For Animal Food Preventive Control compliance dates, they are staggered between complying with the cGMP portion and the Preventive Controls portion. Large Animal Food processors (>500 employees) had to be in compliance with cGMPs in September 2016 and the Preventive Controls by September 2017. Importers had to be in compliance with the FSVP on large Animal Food processors in May 2017. As of right now, large Animal Food processors do not have to have Preventive Controls just yet, only the cGMPs, but the importer still needs to be in compliance with the FSVP.

 

Now to be in compliance with the FSVP, the importer has to conduct a hazard analysis, supplier approval/evaluation, and verification of the Preventive Controls set by the supplier to the hazards determined. If large Animal Food processors do not have to set up Preventive Controls for hazards until September 2017, how can the importer conduct verification activities of those Preventive Controls that are not in place?

 

Since that isn't possible, it leads to my question: what is needed to be in compliance with the FSVP with large Animal Food processors? 


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#6 Charles.C

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Posted 04 July 2017 - 01:07 AM

Hi Franklin,

 

(I confess I stopped visiting/re-visiting the CFR treatise  on FSMA when i failed to find any coherent answer as to why FDA chose to "innovate" traditional hazard analysis).

 

Regardless of dating logistical problems, I assume that, as I understand, the basic CFR/FDA  stated  2 options for haccp requirements for animal food  importers/suppliers are same as human. If not the following will probaby not make much sense.

 

If so, despite the dates mismatch you mentioned , option 1 remains in Principle feasible IMO but might result in a further increased (>= September ) SAHCODHA-ty[e  decision dilemma as was discussed here for human food -

http://www.ifsqn.com...rd/#entry113320

 

In contrast, If Option 1 is not available at all, the Preventive Rule "conundrum" associated with Option 2 seems to generate as (I think) you point out  an "indeterminate". ?. And  the onus to correct due the dating mismatch then seems IMO to be 100% "in FDA's court." Maybe FDA are (silently) intending no probing actions prior September ?

 

Any US animal food importers reading this ?


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Charles.C


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#7 FurFarmandFork

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Posted 05 July 2017 - 08:12 PM

Ditto to Charles above.

 

At this point, you can partially count on poor inspection from FDA. What I would do is try to meet the requirements of FSVP, but allow for an "intermediate/developing" status for your suppliers that allows you to use much of your same verification you're already doing (e.g. HACCP based evaluations vs PC). I would think that if your program is in a "development" state though 2018 while bringing on each component as they take effect, your audits will go smoothly until all rules finally take effect.

 

Pending that, I would see if you can reach out through LinkedIn to some other QA people involved in animal foods. QA people are typically willing to help each other out though you may simply get answers that just say "idk, we're just going to implement everything now".

 

Either count on FDA to be similarly in a state of unequal enforcement when audits occur between the compliance dates, or make your best effort to implement the rules now.


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#8 FurFarmandFork

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Posted 06 July 2017 - 02:41 PM

Hey Franklin12, it looks like FDA posted some additional guidance on what the expectations are today:

 

https://www.fda.gov/...rce=govdelivery


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#9 franklin12

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Posted 06 July 2017 - 04:15 PM

Hey FurFarmandFork,

 

Thank you for the link. That helps clarify that I just need to verify they have cGMPs in place as of now. A bit of a tangent, but within the article they state:

 

"And I want to clarify that importers have some flexibility with respect to the PC and produce safety rules. Importers will need to have a program that allows them to demonstrate that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the PC or produce rules."

 

The way the statement is written could be taken as the foreign supplier does not need to be in exact compliance with the PC rule, but rather have a robust food safety management system, e.g. GFSI benchmarked scheme, would suffice. Thoughts on this?


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#10 Charles.C

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Posted 07 July 2017 - 05:43 AM

Hey FurFarmandFork,

 

Thank you for the link. That helps clarify that I just need to verify they have cGMPs in place as of now. A bit of a tangent, but within the article they state:

 

"And I want to clarify that importers have some flexibility with respect to the PC and produce safety rules. Importers will need to have a program that allows them to demonstrate that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the PC or produce rules."

 

The way the statement is written could be taken as the foreign supplier does not need to be in exact compliance with the PC rule, but rather have a robust food safety management system, e.g. GFSI benchmarked scheme, would suffice. Thoughts on this?

 

I interpret the above quoted text as meaning that the FDA are covering their back in advance of foreseeable headaches.

 

Unless they define which PCs (and PRPs?) are minimally mandatory for a given process (as was done for FDA Seafood haccp) any haccp/harpc "program" must  surely be subjective.

 

I believe that  FDA have offered specific  examples  of the type of "programs" they minimally require for human food. Animal food ?

 

PS - I love the UNK scheme. How to admit a logistic screw-up without actually saying so. :thumbup:


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Kind Regards,

 

Charles.C





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